Precision Medicine Group

Role Description Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology? Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery? Precision for Medicine is looking to hire a (Senior) Project Manager with experience in Oncology who has managed full service clinical trials within a CRO setting to join our global team. In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology. You will be accountable for: - Clinical project delivery - Oversight of all functional departments - Ensuring agreed timelines, scope, cost and quality You will be involved in all study stages, including: - Proposal strategy - Development - Costing - Bid defence - Seeing studies through the full cycle to completion You will manage: - The client relationship - The project team - The budget and timelines throughout You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team. We offer an amazing high-energy, dedicated, collaborative team who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and seek positive teamwork to deliver extraordinary work, we have an opportunity for you. How we will keep you busy and support your growth: - Independently lead clinical projects in accordance with the study budget and scope of work - Use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects - Run international trials as needed - Serve as the primary point-of-contact liaison with the client to provide excellent customer service - Liaise with Project Team and senior management of both Precision and sponsors, including C level - Handle and lead all aspects of a clinical research trial or trials - Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics - Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation - Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials - Prepare and review protocols and other study documentation such as project plans, informed consents, site contracts and budgets Qualifications - Degree or similar related life science qualification, or equivalent combination of education and experience - Previous experience in a full service/global Project Management role working in the CRO industry is essential - 5 to 7 years industry experience and at least 4 years full service Project Management experience in a clinical trial setting working for a Clinical Research Organisation - Experience managing studies within Oncology - Working understanding of GCP/ICH guidelines and the clinical development process - Ability to drive and availability for domestic and international travel including overnight stays - Effective communication skills in the English language both written and spoken - Strong presentation skills - Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS) - Proven ability to develop positive working relationships with individuals and teams internally and externally - Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan Benefits - Precision for Medicine's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology - Supportive and collaborative environment which promotes work-life balance and encourages team development - Opportunity to learn more about our growing organization serving clients researching ground-breaking cancer therapies - Employees feel appreciated for the contributions they make every single day 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 We are excited to bring forward-thinking, motivated Consultants to a growing team; great collaborators who enjoy a challenge, thrive in the details and flourish in dynamic environments. Do you consider yourself a self-starter with an attitude and a strong desire to learn and grow rapidly? Are you passionate about putting in the hard work to conduct high quality research? Do you have strong interpersonal and relationship building skills, and the ability to build credibility with project partners? Do you love to develop and deliver polished PowerPoint presentations? Your dream job is waiting. If you’re a born problem-solver and enjoy when no day is the same - keep reading. What you can expect day-to-day: - Actively participate in the development and delivery of all client outputs. - Staffed on multiple projects in parallel allowing for broad exposure to the wide range of projects and clients. - Demonstrate analytical skills to derive insights and tackle problems. - Support business development activities and practice development. - Engage in mentorship and training activities. Responsibilities include: - Serving as the content expert on your projects. - Synthesizing insights and recommendations from primary and secondary research. - Using internal and external sources to conduct independent desk-based research to address key client questions. - Performing quantitative and qualitative analyses to aid the development of recommendations. - Participating in internal brainstorming sessions to develop thinking and recommendations. - Actively contributing to the preparation, execution and follow up of internal and client meetings. - Preparing presentations and other client deliverables. Consultants also support the day-to-day management of work streams within a large project or project lead smaller projects. Project responsibilities would include: - Support in defining research methodologies to achieve client goals. - Leading primary research. - Providing guidance on secondary research and project direction, in conjunction with project lead. - Owning select client interactions, including running weekly status updates, leading project deliverable presentations, and communicating internally and externally regarding critical issues, new insights and questions to clarify and maintain alignment of work with client needs. Qualifications - Bachelor’s degree. - Consultant: 1-2 years of experience in consulting. - Sr. Consultant: 2-3 years experience in consulting or related business analytics/strategy experience within the healthcare space (pharmaceutical, biotech, medical device, diagnostics industry). - Strong MS Office literacy e.g. Word, PowerPoint, Excel. - Ability and flexibility to travel. - Undergraduate concentration in Economics and or Business. - Master’s or PhD degree in Science, Economic or Business. - Proven interest in the pharmaceutical industry or healthcare consulting; precursory knowledge of US healthcare system and an ability to critically analyze clinical data. Requirements - Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. - The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. - This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. - Reasonable estimate of the current range: $80,000 — $132,000 USD. Benefits - Discretionary annual bonus. - Health insurance. - Retirement savings benefits. - Life insurance and disability benefits. - Parental leave. - Paid time off for sick leave and vacation.

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals • Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams • Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately • Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability • Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues • Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees • Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position • Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems • Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution • Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics • Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process • Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas • Represent Precision for Medicine in a professional manner • Manage CRA staff in accordance with Precision for Medicine’s values and policies • Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans

• Manage the day-to-day activities of the Data Management (DM) function in accordance with Standard Operating Procedures (SOPs) • Responsible for the successful planning, implementation, and execution of DM contracted activities • Provides oversight to data management projects, coordinating inter-departmental and client communication • Supports the Head of Department in functional training, hiring, defining standards, and executing department goals • Acts as the point of contact for internal team and sponsors, ensuring timely task performance • Manages, directs, leads, develops, and supervises data managers • Reviews RFPs, proposals, and related project estimates • Oversees project data entry processes and ensures adherence to project timelines • Responsible for ensuring data quality and timeliness of DM deliverables are met and aligned with business goals • Oversees completeness of data management documentation for the Trial Master File • May liaise with third-party vendors supporting timelines and data-related deliverables.

• Serve as a trusted partner to the Evidence Solutions business to lead all contract operations and see it through to project coordination • Contract operations includes: • Drafting and supporting the revision process on all client, vendor, and subcontractor contracts and amendments using templates and serving as the point of contact for contracting operations with our internal legal team • Utilizing Precision’s legal platform to track and advance all documents through the contracting process from initial draft to signature and ensuring accurate and timely delivery of all contract documents to business leads for submission to clients or subcontractors • Supporting the tracking of key terms and conditions within client MSA documents, alongside legal, to ensure that each Scope of Work (SOW) abides to the key terms of the agreement • Tracking down purchase orders with clients as needed • Archiving all supporting documents inclusive of signed SOWs, purchase orders, and invoices in an organized manner for the business • Project coordination includes: • Assisting the Project Manager by ensuring timely data capture and accuracy in the appropriate systems in relation to project setup, maintenance of project updates and resource assignment • Serve as the primary point of contact between the finance and project teams to initiate and forecast client invoicing based on project status and contract terms • Ensuring subcontractors and vendors have appropriate client project codes for invoice submission for ease of entry to accounts payable • Liaising between clients and internal teams as needed to resolve invoicing questions/support • Leading client portal setup and updates • Additional ad hoc support as needed

• Ability to understand and clearly communicate client business issues, operating business rules, data, and standard operating procedures. • Understand, execute, and suggest improvements to pre-defined operational processes. • Implement process improvements in operational processes and strive to identify such opportunities working with Senior Data Analyst & Operations Delivery Lead. • Remaining current on new tools, techniques and working models to continually improve/enhance process and design for quick adoption. • Develop strong understanding of operational processes, data, tools & technology to effectively translate business to technology & vice versa. • Build subject matter expertise over a period of time and apply it to operational processes. • Apply quality checks and validations on all deliverables and report back results to the Operations Delivery Lead. • Execute defined operational models for our clients with standard operating procedures, quality assurance quality checks, governance criteria, roles and responsibilities and assist the Senior Data Analyst & Operations Delivery Lead to define newer more efficient models including detailed documentation. • Coordinate with multiple stakeholders (could be in different time-zone) of the operational process to ensure smooth delivery to client per pre-existing timelines. • Assist engineering team to implement new operational procedures and/or improvements to existing operational procedures by providing knowledge about operations and testing the modified procedures. • Testing new/updated operational procedures to ensure fidelity. • Coordinate multiple tasks to produce high-quality results. • Work on multiple client tasks, strengthening analytic, task management and communication skills. • Collaborate with internal PMG teams to provide all-round value to the firm. • Keep track of unplanned internal & client tasks stemming from operational projects. • Carry out secondary research as needed. • Investigate client questions related to operational deliveries, as needed.

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Travels as necessary according to project needs. • Performs other duties as assigned by management.

• Provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring) • Ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations • Collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels • Contributes to the development and revision of Clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards • Ensures CRA resources and other Clinical project resources are continuously adequate; interviews and selects CRAs for studies • Coordinates the activities of employees and contract Clinical Operations team members; designates site assignments, tracks and reviews monitoring reports and calendars • Assists in the resolution of employee and contract CRA performance issues, including termination of contracts as needed • Represents Clinical Operations on company-wide project teams • Assists with the Clinical Operations and Project Team Meetings, including development of meeting agendas and minutes • Produces periodic reports • Provides input regarding Clinical Operations for proposals, budgets and contracts; participates in bid defense meetings • May participate in the analysis and development of Clinical Operations and Project Management department budgets • Hires and trains Clinical Operations employees • Development of department job descriptions • Adheres to applicable ethical, regulatory and clinical standards • May perform other duties as assigned • Follow applicable regulations, including FDA, ICH, and Agility Clinical Policies and Procedures • Primary interface with Client representatives as well as Agility Clinical (Agility) personnel in the Project Management, Data Management, Medical and Safety, and Biostatistics departments to ensure the timely initiation and completion of clinical trials • Ensures standards for monitoring and reporting are met • Coordinates study specific training and other requirements for internal and external staff, as appropriate • Assigned to manage full-service, large-scale, complex projects

Role Description The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities. The role focuses on ensuring data integrity, traceability, and compliance with internal SOPs and applicable regulatory expectations, while maintaining strict independence from study execution. This position includes high‑value QA activities that can be performed remotely, with controlled system access and clear separation from operational responsibilities. - Study-Audit Support - Support execution of internal audits by: - Create study-specific audit schedule prior to First patient-in (FIP) for study-specific audit - Create audit plan, execute, and draft the report for each scheduled audit (interim or associated with the final report) using objective, evidence-based language under QA lead oversight - Execute the audit through the review of controlled documents, including: - SOP alignment - Version verification - Study governing documents (Lab manual, Project Specification Document, Data Transfer Agreement, clinical protocol) - Conduct QA review of clinical protocols, sample analysis protocols (SAP/SAR) and amendments, ensuring: - Version verification - Internal consistency - Alignment with study objectives and SOPs - Assure closure of quality events pertaining to study at the time of data reporting - Perform QA review (sampling) of experiment records / batch records, including: - Need access to LIMS/BSI and other systems hosting data source - Ensure alignment between protocol-defined activities and recorded execution - Training status of staff - Qualification status of equipment and reagents - Conduct QA review (sampling) against DTA of data tables, listings, and summaries, including: - Table-to-source traceability (raw data → output) - Internal consistency checks - Sample ID reconciliation and data alignment (BSI) - Apply data integrity (ALCOA+) principles during review of electronic data systems - Computerized Systems Audit Support - Support execution of internal audits by: - Preparing audit checklists - Compiling pre-audit document packages - Assisting with document-based audit reviews - Provide audit preparation support, including: - Evidence list preparation - Pre-audit document collection - Draft audit reports and summaries using objective, evidence-based language under QA lead oversight - Data Integrity Assessment - Conduct data integrity audits of paper and electronic records - Evaluate: - Audit trails and metadata - System controls (e.g., access, security, validation) - Data lifecycle controls (collection, processing, reporting) - Assess compliance with: - ALCOA+ principles - 21 CFR Part 11 / Annex 11 for electronic systems - Identify: - Data discrepancies, manipulation risks, or gaps - System vulnerabilities affecting data reliability - Miscellaneous: - Assist in training new and existing personnel, as needed - Participate in regulatory, notified body, and customer audits as needed - Provide back-up coverage for other Quality Specialists - Carry out other duties/projects as assigned Qualifications - Bachelor’s Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry - 4 years of related experience in a life science GxP environment with CRO experience preferred - Hands-on experience with: - ICH-GCP (E6 R2/R3) - FDA regulations (e.g., 21 CFR Part 11) - EMA / EU CTR / Annex 11 - GxP frameworks (GCP, GMP, GLP, GCLP) - Preferred certification: - ASQ Certified Quality Auditor (CQA) - ISO 9001 / ISO 13485 Lead Auditor - GxP Lead Auditor certifications (e.g., CQI/IRCA) - Clinical QA certifications (e.g., CCQAP) Requirements - High attention to detail - Strong written and verbal communication - Ability to meet deadlines and perform administrative functions - Data review expertise across computerized systems including LIMS - Understanding of Audit trails, metadata, and system validation - Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA) - Data governance frameworks - Must be able to interpret raw data vs reported data discrepancies - 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 - Demonstrated 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 Company Description

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. Company Description