Parexel

Role Description The Clinical Research Associate is responsible for the following: - Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Key Accountabilities: Site Management Responsibilities - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates and provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: - Data generated at site are complete, accurate and unbiased. - Subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager. - Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines. Team Development and Support - Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audits/inspection activities as needed. - Performs co-monitoring visits where appropriate. Compliance with Parexel Standards - Complies with required training curriculum. - Completes timesheets accurately as required. - Submits expense reports as required. - Updates CV as required. - Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. Qualifications - Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices. - Proven skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgement. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, working solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. - Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. - Able to work highly independently across multiple protocols, sites, and therapy areas. - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. - Demonstrates commitment to Customer focus. - Works with high quality and compliance mindset. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. - Ability to travel domestically and internationally approximately 65%-75% of working time. - Current driver’s license required. Requirements - Minimum 2 years of direct site monitoring experience in bio/pharma/CRO. - Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs. Education - Bachelor’s degree preferred with a strong emphasis in science and/or biology. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Role Description When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: - Oversight of activities - Program moderately complex data review listings, exception reports, and metrics reports in a fast-paced environment for clinical trial data review and management purposes - Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly - Create and document archives of software and deliverables - Support company’s CDF and other platforms, including software updates and patch fixes - Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables - Responsible for training options, user access and technical support in relation to the company’s CDF and other CDM information systems - Cultivate and disseminate knowledge of application-usage best practices - Responsible for maintaining system and end user requirements documentation - Responsible for implementing solutions to ensure GxP compliance - Liaise with Clinical Data Management staff to understand the needs of the end users of the listings, reports, and metrics Qualifications - Ability to work in a cross-functional team environment - Adept in end-to-end administration emphasis on analysis, development, design, testing and implementation of various projects Requirements - Thorough knowledge of clinical trial study design, data collection and the drug development processes - Experience with CDASH standards - Familiarity with clinical data sets from major EDC systems (e.g., Medidata Rave, InForm, TrialMaster), safety systems (Argus), and CTMS systems - Understanding of clinical data structures, relational database structures, and data exchange - In depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC] - Knowledge of ICH E6 (R2) Risk Based Monitoring a plus - Experience with SAS, T-SQL, and Qlik (preferred) - Minimum of 5 years of relevant experience Education - Bachelor’s Degree is required; degree in life science or related discipline preferred Company Description Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Role Description We're looking for an Initiation Clinical Research Associate to lead the startup and activation phase of clinical trials. You'll be the key point of contact between Parexel and our clinical sites, driving strategy from site identification through activation while ensuring regulatory compliance and first-time quality across all deliverables. The role is based remotely in Serbia, so you must reside in Serbia and have the right to work there. Second languages preferable (French, Polish, Danish, Swedish, Finnish, Hungarian, Spanish). What You'll Do - Own site startup: Build strong relationships with investigators and site staff, manage qualification visits, and guide sites through regulatory approvals (IRB/IEC, MoH/RA). - Drive regulatory excellence: Prepare and negotiate ICFs, manage protocol amendments, and ensure all documentation meets regulatory requirements. - Ensure readiness: Coordinate training, system access, and compliance checks so sites launch on time and audit-ready. - Manage the details: Maintain CTMS and eTMF records with first-time quality; resolve site issues proactively. - Think strategically: Forecast timelines, identify risks early, and develop solutions independently. Qualifications - Self-driven problem-solver who takes initiative and works independently. - Strong communicator with excellent interpersonal skills. - Organized multi-tasker who thrives in a matrix environment. - Detail-oriented with proven clinical research experience. - Proficient in CTMS, eTMF, and MS Office. - Comfortable working across cultures and virtual teams. Requirements - Level II: Substantial startup experience in clinical research. - Level I: Some startup experience or knowledge of in clinical research. - Degree in biological science, pharmacy, nursing, or health-related field (or equivalent experience). - Knowledge of ICH-GCP guidelines and clinical trial methodology. - Proficient in Serbian language. - Second languages preferable (French, Polish, Danish, Swedish, Finnish, Hungarian, Spanish). - Ability to make sound decisions in ambiguous situations and work with urgency.

Role Description When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities - Project Management - Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. - Statistical Programming for Assigned Projects - Deliver best value and high quality service. - Check own work in an ongoing way to ensure first-time quality. - Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. - Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. - Training - Maintain and expand local and international regulatory knowledge within the clinical industry. - Develop knowledge of SAS and processes/procedures within other Parexel functional areas. - Provide relevant training and mentorship to staff and project teams as appropriate. - General - Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance. - Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. - Proactively participate in process/quality improvement initiatives. - Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Qualifications - Excellent analytical skills. - Proficiency in SAS. - Knowledge and understanding of the programming and reporting process. - Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. - Ability to learn new systems and function in an evolving technical environment. - Ability to manage competing priorities and flexibility to change. - Attention to detail. - Ability to successfully work as part of a global team. - Work effectively in a quality-focused environment. - Effective time management in order to meet daily metrics or team objectives. - Show commitment to and perform consistently high quality work. - Business/operational skills that include customer focus, commitment to quality management, and problem solving. Knowledge and Experience - Competent in written and oral English. - Good communication skills. Education - Educated to degree level in a relevant discipline and/or equivalent work experience.

• Manage Projects & Technology • Lead and implement Data Receipt Agreements with vendors in collaboration with cross-functional teams • Program and establish import procedures for data ingestion using SAS or alternative technologies (e.g., Workbench) • Design and implement reconciliation checks to ensure accurate data transfer • Program offline listings and custom reports to provide valuable insights on external data • Aggregate data across all sources and manage data structures, missing values, and programming errors • Review data outputs and provide strategic insights to study teams and clients • Ensure first-time quality on all deliverables • Negotiate electronic data timelines and ensure adherence through active project management • Monitor project resourcing, identify scope changes, and resolve technical issues • Coordinate and lead programming teams to successful project completion within timelines and budget • Manage deployment of data management technology for offline listing creation • Act as SME and technology owner for data management offline listing platforms • Maintain comprehensive supporting documentation in accordance with SOPs, Guidelines, and Work Instructions • Ensure traceability and regulatory compliance across all study activities • Document deviations and communicate them to project teams • Support Initiatives & Continuous Improvement • Participate in creating standards through tools (SAS macros), libraries, and processes • Develop and implement project-specific tools and improvements • Lead or drive global initiatives related to processes and new technologies • Mentor staff and provide relevant training • Assist project teams in problem resolution and technical support • Maintain and expand regulatory knowledge within the clinical research industry • Serve as point of contact for clients and internal stakeholders on electronic data matters • Participate in bid defense meetings • Independently contribute ideas on technology and data engineering to support business development

• Lead a small clinical study or co-lead a larger study or studies with moderate guidance. • Be able to support several clinical studies with minimal guidance. • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies. • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. • Be able to perform a thoroughly detailed review of eCRF data requirements. • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. • Develop data edit check specifications and run data listings as required. • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. • Able to resolve EDC system issues with team members. • Develop the Data Management Plan for a clinical study. • Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications. • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries. • Perform reconciliation of header data from external data sources against the clinical database. • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines. • Assist in database upgrades/migrations including performing User Acceptance Testing. • Able to maintain study workbooks and data management files. • Perform database lock and freeze activities per company SOPs. • Participate in regular team meetings and provide input when appropriate. • Provide input into the development of data management SOPs, Work Instructions, and process documents. • Assist with the training of new employees and/or contractors. • Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.

• The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio • Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs) • Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs) • Conducting critical appraisal and systematic review of literature with a focus on background epidemiology • Performing aggregate report compliance activities including quality review • Coordinates and liaises with the members of Study Management Team (SMT) • Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client • Responsible for the end-to-end signal management process

Role Description The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals. Key Accountabilities: - Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs), preparing health authority response document along with RMS update in accordance with client requirements/conventions and SOPs. - Managing scheduled and unscheduled aggregate reports including but not limited to: - Periodic Safety Update Reports (PSURs) - Periodic Benefit Risk Evaluation Reports (PBRERs) - Addendum to Clinical Overviews (ACOs) - Semi-Annual Safety Reports (SASRs) - Corporate Addendum Reports - United States Periodic Adverse Drug Experience Reports (PADERs) - Development Safety Update Reports (DSURs) - Annual Risk-Benefit Evaluation (ARBE) report - Risk Management Plan (RMP) - Safety statements - Health Hazard Evaluation (HHE) - Drug Safety Report (DSR) - Clinical Overview (CO) - Safety Evaluation Report (SER) - Investigational New Drug Annual Report (INDARs) - Comparison document between local and global labeling document (if applicable) - Conducting critical appraisal and systematic review of literature with a focus on background epidemiology. - Providing input and developing literature search strategies for the epidemiology section of safety reports. - Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports. - Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various types of aggregate reports. - Generating Line Listings for submissions to identify discrepancies and ensuring resolution of the discrepancies. - Distribution of final reports to stakeholders including partners, affiliates, and submission to health authorities. - Scheduling and coordinating meetings, drafting meeting agenda and minutes, tracking action items, and soliciting follow-up for open issues. - Coordinates and liaises with the members of Study Management Team (SMT) to discuss the narrative template development process. - Serves as primary client contact for narrative writing for an assigned study. - Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client. - Performs quality checks on the drafted narratives as required. - Ensures the work is complete and of high quality, including final quality control checks, compilation, and formatting. - Provides CSR narrative review support to the SMT where requested. - Perform signal detection review and analysis from various sources. - Responsible for the end-to-end signal management process in collaboration with the GSO. - Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs. - Attending/conducting internal, drug safety, and project-specific training sessions. - Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents. - Preparation for, participation in, and follow-up on audits and inspections. - Striving to enhance client satisfaction based on feedback provided by the client. - Acting in the capacity of lead, which may entail serving as the primary client contact. - Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work. - Mentoring new recruits in the team, if required. - Archiving the source documents and relevant emails as required. - Responding to clients/customers in a timely manner. Qualifications - 5+ years of direct experience in Regulatory Writing in a CRO or Pharma company setting. - Good knowledge of medical terminologies. Requirements - Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences. - A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing is an advantage. Company Description Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

• Lead and implement Data Receipt Agreements with vendors through cross-functional collaboration • Program and configure import procedures for data ingestion using SAS, Workbench, or alternative technologies • Design and execute reconciliation checks to ensure accurate data transfer • Program offline listings and custom reports to provide actionable insights • Aggregate data across multiple sources and manage external data effectively • Handle missing values, raw data files, data structures, and SAS dataset operations • Review and analyze data outputs to provide insights to study teams and clients • Ensure first-time quality on all deliverables • Manage electronic data timelines and coordinate with project teams • Lead programming teams to successful study completion within timelines and budget • Deploy and manage data management technology (Workbench, SAS, R, etc.) • Maintain comprehensive study documentation in accordance with SOPs, guidelines, and work instructions • Ensure traceability and regulatory compliance across all activities • Document deviations and communicate them to project teams • Participate in creating standards through tools (SAS macros, libraries, processes) • Develop and implement project-specific tools and templates • Improve efficiencies through standardized project structures and naming conventions • Support business development and bid defense meetings

• Draft, review and negotiate site agreements including clinical study agreements, service agreements, and team member agreements • Provide context to comments received from sites based on legal and business framework • Manage the contract execution process • Develop and maintain positive relationships with clinical trial sites • Track and report on the statuses of site contracting activities