Precision for Medicine

Role Description The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. - Serve as primary point-of-contact and primary escalation point to the client. - Coordinate and oversee all functional services including external vendors to the established timeline and budget. - Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. - Independently drive the CO to completion and execution with support as needed. - Maintain integrated collaboration with clinical operations in the delivery and participate in clinical activities as appropriate. - For projects of very limited scope, Sr. PM may assume all clinical activities. - Manage the financial health of assigned studies, including oversight of project profitability, billable project hours, and compliance with on-time, accurate billing and forecasting. - Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation. - Ensure quality management for assigned projects, including eTMF Inspection readiness and implementation of quality notification incident forms. - Maintain integrated collaboration with all functional operations in the delivery of the program. - Establish tracking metrics to monitor trial and team progress towards project goals. - Prepare project status updates and report on progress to clients and senior management. - Lead both internal and client meetings and set expectations for the project team. - Communicate effectively with client and Precision management to relay protocol/study issues. - Conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients. - Ensure study specific training is implemented in collaboration with functional areas. - Support business development and marketing activities as appropriate. - Perform other duties as assigned by management. - Remain compliant with organizational training, time-reporting, and any other administrative duties. - Provide ongoing feedback for functional team members including annual performance reviews. Qualifications - North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. - EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. - Minimum of 7 years of clinical research experience or proven competencies for this position. - Minimum of 4 years of direct project management experience. - Experience in managing complex and global trials. - Ability to travel domestically and internationally including overnight stays. - Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS. - Proven communication and interpersonal skills to effectively interface with others in a team setting. - Proven organizational skills, attention to detail, and a customer service demeanor. Requirements - Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items. - Direct work experience in a global, cross-functional project management environment. - Good understanding of cross-functional management. - Good understanding of project planning, risk management, and change management with an awareness of appropriate escalation. - Proven experience in strategic planning, risk management, and change management. - High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective. - Ability to lead and inspire excellence within a study team. - Ability to create an environment where study team members have a sense of ownership. - Results oriented, accountable, motivated, and flexible. - Proven time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills. - Proven presentation, verbal, and written communications skills. - Good understanding of project management software. - In-depth proven experience in pharmaceutical and/or device research required. - Radiopharmaceutical trial experience strongly preferred. - Preferred: experience with oncology & cell and/or gene therapy. Benefits - Discretionary annual bonus. - Health insurance. - Retirement savings benefits. - Life insurance and disability benefits. - Parental leave. - Paid time off for sick leave and vacation.

Role Description We are hiring a Clinical Research Associate II, this position will be fully home based working in the UK or Northern Ireland. - You will monitor and own the progress of clinical studies at investigative sites. - Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. - Coordinate all necessary activities required to set up and monitor a study: - Identify investigators. - Help prepare regulatory submissions. - Conduct pre-study and initiation visits. Qualifications - Minimum Required: 4-year college degree or equivalent experience. - Other Required: - More than 1 year CRA experience within the CRO or pharmaceutical industry. - Oncology experience, early phase experience desirable although not essential. - Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions). - Fluency in English. Requirements - You are calm, thoughtful, and responsive when things don’t go as planned. - You are well-prepared for investigator meetings, site visits, or project team updates. - You find quick and creative ways of overcoming difficulties. - You have an impeccable eye for detail. - You identify potential study risks and propose solutions on how to mitigate them. - You take responsibility for the quality and outcomes of your work. - You are adept at handling conflict using tried and true resolution strategies. Benefits - High CRA retention rates compared to industry averages. - Lower than average number of protocols, setting you up to be a protocol expert. - Reasonable travel and improved work/life balance. - Your voice will be heard, allowing you to have influence and impact. - Support from direct line management. Company Description Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Precision’s uniquely integrated offering enables the science of precision medicine by combining: - Novel clinical trial designs. - Industry-leading operational and medical experts. - Advanced biomarker and data analytics solutions. - A passion for rare diseases and oncology. We invite you to learn more about our growing organization serving clients researching groundbreaking cancer therapies.

Role Description The Specialist, Sample Management is responsible for the support, coordination, and training of Sample Management activities and initiatives focused on discrepancy tracking and resolution. - Maintain global oversight of unresolved discrepancies identified by internal sample management teams for both incoming and outgoing shipments. - Work directly with sample management teams to receive any additional clarification or justification as needed. - Communicate and/or execute appropriate resolution actions to close discrepancies in a timely manner to meet customer and business deliverables on TAT and OTIF. - Identify and consult on trends related to sample discrepancies observed with internal teams, collection sites, and/or established data entry/study requirements. - Provide necessary study close-out support for sample management including internal assessment of data, sample dispositions and resolve any reconciliation queries and actions. - Perform quality control (QC) verification of data entry performed by global sample management teams to ensure compliance/alignment to data entry requirements. - Identify, and clarify as needed, data corrections stemming from misalignments observed from prescribed data entry requirements. - Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems. - Study setup in LIMS, including protocol configuration and sample workflow parameters. - Monitor patient sample collection schedules and protocol-defined assessment windows to ensure timely and compliant sample receipt. - Prepare and maintain operational reports including sample inventory, kit tracking, and site performance metrics. - Participate in root cause analysis and corrective actions for sample-related quality events. - Assist with documentation of sample related issues, corrections and compliance with QMS standards. - Support ad hoc requests for analysis and other duties as assigned. Qualifications - Minimum of 2-3 years of relevant experience. - Comprehensive understanding of drug, device, and/or biologic development processes. - Experience with clinical database management systems. - Strong expertise in data quality standards and practices. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). - Excellent organizational, written, and verbal communication skills in English. Requirements - Bachelor’s / master’s degree in a life science related field (preferred). - Background in clinical, scientific, or healthcare disciplines (preferred). - Familiarity with data privacy regulations (e.g., GDPR, HIPAA) (preferred). - Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems (preferred). Company Description Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com. Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers.

Role Description We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM! Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master Files in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio. - Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality. - Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team. - Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF. - Attend and contribute to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations. - Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. - Ensure that TMF Risks are identified and appropriately documented and mitigated. - Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required. - Identify trends, risks, and overall status of the TMF and suggest mitigation strategies. - Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management. - Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation. - Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis. - Identify project team TMF training needs and provide or support team re-education. - Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt. - Where needed, manage projects within the Sponsor eTMF System. - Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support. Qualifications - Bachelor’s degree (or its international equivalent). - A minimum of 3 years of related experience or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job. - Professional working proficiency in English. Requirements - Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint). - Experience with eTMF systems and vendors. - Working knowledge of FDA & ICH/GCP regulations and guidelines. - Demonstrates solid interpersonal skills. - Ability to identify issues and escalate appropriately and effectively. - Good organizational skills, time management, and ability to coordinate workload and meet established deadlines. - Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. - Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. - Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders. - Communicates both verbally and in written form in an efficient and professional manner. - Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Company Description

Role Description The Quality Assurance Specialist I (Supplier Management Support) will provide hands-on support to the Supplier Management Program maintenance. Activities include but are not limited to: - Supplier qualification - Audit assistance - Support for supplier complaints - Agreement preparation - Timely communication of supplier management KPIs to key stakeholders In addition, this position is responsible for providing backup for its peers as needed. Essential functions of the job include but are not limited to: - Support the maintenance of an effective Supplier Management process by: - Supporting supplier qualifications - Managing and organizing supplier documentations - Assisting in scheduling supplier audits - Supporting the maintenance of the Approved Supplier List in a current state - Preparing and managing Quality Agreements with suppliers - Managing SCAR in a timely manner - Sharing supplier notifications with appropriate key stakeholders - Helping with compiling and reporting of monthly KPIs - This role may also support the quality team with other responsibilities such as non-conforming events, complaints, and change control. Qualifications - Minimum Required: - Bachelor’s degree or equivalent combination of education and experience - 2 years of related Quality Assurance experience in a life science, regulated environment - Other Required: - Ability to meet deadlines and perform administrative functions - Microsoft Office suite proficiency including Office Word, Excel, PowerPoint - Ability to organize tasks, work independently and adapt to changing priorities - Ability to function independently within a minimally supervised environment with exceptional attention to detail required - Demonstrate highly developed communication skills including well-developed writing skills and verbal and interpersonal skills - Must be able to read, write, speak fluently and comprehend the English language - Extended work hours may be necessary to meet the business demands - Preferred: - Experience working in a Quality Department/Life Sciences-Regulated environment including supplier management Company Description

Role Description As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team. - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. - Interaction with CA/EC for study purposes and handling responses to the CA/EC. - Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. - Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. - Customize country/site specific Patient Information Sheet and Informed Consent Form. - Responsible for/facilitates the translation and co-ordination of translations for documents. - Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. - When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. - May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. - Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. - Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. - May support the clinical team performing Pre-Study Site Visits. Qualifications - Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. - A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. - 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Requirements - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Company Description Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

Role Description The Senior People Operations Partner provides advanced operational HR leadership across multiple countries or complex jurisdictions within the global HR operating model. The role supports high-complexity employee relations matters, organisational change, country expansion activity, and employee representative or works council processes where applicable. Acting as a senior operational HR expert, the role partners closely with HRBPs, Legal, Payroll, business leadership, and Global People Services to ensure compliant, scalable, and effective HR operational delivery across regions. The Senior People Operations Partner also plays a key role in operational governance, transformation initiatives, mentoring and driving consistency across the People Operations model. Responsibilities - Multi-Country Operational HR Leadership - Provide advanced operational HR support across multiple countries or complex jurisdictions. - Lead operational delivery of organisational changes, restructures, transfers, integrations, and workforce transitions. - Support operational readiness and implementation of country expansions and new market entry activity. - Ensure operational consistency while balancing local legislative and cultural requirements. - Complex Employee Relations & Legislative Support - Lead or support complex employee relations matters including investigations, grievances, disciplinary matters, restructures, and sensitive exits. - Partner with Legal and HR leadership on high-risk or legally sensitive operational matters. - Support Works Councils, CSEs, or employee representative processes where applicable. - Ensure operational compliance with local labour laws, consultation obligations, collective agreements, and statutory requirements. - Operational Governance & Escalation - Act as a senior escalation point for complex operational HR matters requiring advanced judgement. - Drive operational governance, consistency, and best practice across supported countries. - Support development of operational frameworks, SOPs, and escalation models. - Provide coaching and guidance to Global People Services team members. - Strategic Operational Partnership - Partner with HRBPs and business leaders to operationalise workforce and organisational changes. - Provide operational input into workforce planning, transformation, and business change initiatives. - Support implementation of HR operating model improvements and operational transformation initiatives. - Continuous Improvement & Transformation - Lead operational improvement initiatives across regions or functions. - Support implementation of HR technology, automation and scalable operational processes. - Identify operational trends, risks and process improvement opportunities. - Contribute to broader HR transformation and governance initiatives. Qualifications - Degree in Human Resources, Business Administration or related field preferred. - Professional HR qualification (e.g. CIPD, SHRM, HRCI or equivalent) desirable. - Advanced multi-country or regional HR operational experience required. Requirements - Significant HR generalist and operational HR experience across multiple countries or regions. - Strong experience managing complex employee relations and legislative matters. - Experience supporting Works Councils, CSEs, or employee consultation processes preferred. - Experience supporting organisational change, transformation, or country expansion activity. - Strong operational judgement and risk assessment capability. - Excellent stakeholder management and influencing skills. - Ability to coach and guide operational HR team members. - Strong organisational and project coordination capability. Company Description Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.

Role Description The In-house CRA I provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The In-house CRA I is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities. - Assists with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites. - May assist in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating, and reviewing responses to site recruitment questionnaires. - Schedules internal and external meetings as required. - Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required. - Assists in ongoing essential document collection and review, maintenance, and close-out activities, assisting in organizing and maintaining site level data in the trial master file (TMF) ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations. - Assists with sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines. Utilizes the Clinical Trial Management System (CTMS) to ensure milestones and activities are accurately tracked. - Acts as site contact/liaison for study and site management issues including addressing questions, assists with managing study supplies, and may support offsite central monitoring activities. Escalates issues and risks as needed. - Ensures timely and complete data entry by site in EDC or any other system that requires data entry. - Sends email blasts/newsletter, updates, and updated study core documents to study site personnel. - Assists in providing logistics support in samples management and tracking, where applicable and in study supply management. - Supports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements. - Assists in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures as per study plans. - Assists with study tracking via the CTMS, Study specific trackers or Sponsor designated system to ensure that the study reporting is current, accurate and complete. - Documents site and Sponsor contact and study interactions in a timely and professional manner. - Assists in remote review of the electronic Investigator Site File, where applicable. - Assists with Investigational Product accountability, where applicable. - Consults with project team members regarding study site issues. - Provides quality review of the amended site level informed consent template under supervision. - Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments. - May attend site visits as needed, supporting the CRA to ensure sponsor and investigator obligations related to the study documentation are being met and are compliant with applicable regulatory requirements and guidelines. - Performs other duties as assigned by management. - Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements. Qualifications - Minimum Required: Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline. - Proven competencies to learn the skills to serve in this role. - Other required: Advanced knowledge of the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). - Customer service demeanor; demonstrate flexibility and teamwork. - Ability to focus on detail for extended periods of time, high attention to accuracy. - Ability to communicate both verbally and in writing in English. - Having transferrable skills from a related health care field. - Ability to travel as needed. Requirements - Good organizational skills. - Ability to work efficiently in a remote work environment. Competencies - Ability to develop a working knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance. - Demonstrates solid interpersonal skills. - Exhibits self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. - Good written and verbal communication skills and presentation skills. - Demonstrate ability to deliver on commitments. - Commitment to performing professionally consistent with Precision Principles.

Role Description Support role which works with internal teams to review, update, and assist with the completion of study startup documents with oversight from a Study Design Lead. Assists with administrative tasks. - Works on problems of limited scope; follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. - Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. - Contacts are solely internal to the company on routine matters. Builds productive internal working relationships. - Normally receives detailed instructions on all work. - Understand and complete revision requests accurately and work closely with internal teams to execute them efficiently. - Work with internal teams to successfully coordinate the completion of design documents for lab services. - Ensure all customer requirements are documented appropriately. - Ensure that work product complies with design and performance standards, regulatory environment and customer expectations; enforce standards applicable to each step in project execution. - Assist in development of the Project Specifications Document, with stakeholder input, to document requirements for Lab Manual, Kit Design, Kit Components, Couriers, Sample Management, Sample Processing, and Lab Database; assist in development of the Lab Manual and Project Operating Procedure for Precision Labs. - Assist with the review and update of all documentation associated with project(s) to approvable status. - Build strong relationships to ensure high quality study design; collaborate with key stakeholders from PM, Clinical, and Lab on study design. - Coordinate with other project staff to identify and consolidate support processes. - Monitor assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. Completes additional tasks needed in support of project, customer and departmental objectives. - Complete other responsibilities, as assigned. Qualifications - Minimum Required: Bachelor's degree in a life science or related field (e.g., engineering). - Excellent computer skills and experience with MS Office/MS 365 applications. - Excellent communication, interpersonal, organizational, and multi-tasking skills; skilled emotional intelligence. - Able to work in front of a computer for long hours at a time. - Strong understanding of technical writing and data analysis. - Strong critical thinking, analytical, and problem-solving skills. - Exceptional research and reporting skills; ability to convert research to valuable insights. - Extended work hours may be necessary in order to meet business demands. - Strong presentation skills. - Excellent use of judgment and discretion. - Able to read, write, and fluently speak and comprehend the English language. - Proven track record of being a team player and leader, willing to interact proactively and productively. Company Description Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Role Description As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team. - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. - Interaction with CA/EC for study purposes and handling responses to the CA/EC. - Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. - Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. - Customize country/site specific Patient Information Sheet and Informed Consent Form. - Responsible for/facilitates the translation and co-ordination of translations for documents. - Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. - When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. - May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. - Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. - Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. - May support the clinical team performing Pre-Study Site Visits. Qualifications - Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. - A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. - 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Requirements - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Company Description Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.