Clinical Data Manager II

Compass Therapeutics, Inc. was founded in 2014 and is headquartered in Boston, MA. We are an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics to treat multiple diseases. Our robust pipeline currently includes four clinical assets spanning all phases of development, with novel mechanisms of action, and first-in-class or best-in-class potential across multiple tumor types. Our lead clinical-stage asset, tovecimig, has completed a randomized late-stage biliary tract cancer study and we are preparing for a BLA submission. We are now at an exciting inflection point as we build out a commercial organization to support our first product launch. This is a unique and pivotal moment to join us and help make a meaningful impact on patients’ lives. For more information, visit www.compasstherapeutics.com. Our Biometrics team is seeking a highly motivated and hands-on Clinical Data Manager II to support our oncology clinical programs. The ideal candidate will have demonstrated experience overseeing CROs, managing and validating external data, and ensuring high-quality clinical trial data from study start-up through database lock. This individual will thrive in a fast-paced, collaborative environment and will report to the Director of Biometrics. This position reports onsite 4 days/week in our office in Brighton, MA. Responsibilities: Ensure that Compass Clinical and Data Management goals are on track to reach milestones within timelines, while adhering to project and study team expectations regarding quality, time and cost, and applicable regulationsServe as the primary contact overseeing data management across multiple CRO partners and other external vendors across relevant clinical programs, including managing expectations, deliverables, data workflows, quality, issue resolution, and compliance with protocols, internal procedures, GCP, applicable regulatory guidelines, company policies, and SOPsEstablish data transfer guidelines and agreements with CROs and external data vendors; oversee the receipt, integration, validation, reconciliation, review, and transfer of external clinical data in accordance with study timelines and requirementsProvide a high level of expertise and guidance in data management to support clinical studiesLead the establishment and optimization of Clinical Data Management (CDM) processes, including identifying, authoring, reviewing, implementing, and maintaining SOPs and Work Instructions to ensure compliance with regulatory requirements, GCP, and ICH guidelines; support cross-functional process definition, innovation, and continuous improvement of clinical data management activitiesLead and oversee the design and creation of clinical trial study databases and perform Sponsor User Acceptance Testing (UAT) activities for database builds and subsequent database modificationsProvide strategic data management expertise and guidance to clinical project/study teams to optimize study-specific clinical trial processes and ensure high-quality, timely, and cost-effective deliveryCollaborate with cross-functional partners to develop project and study timelines and maintain internal data management timelines, ensuring deliverables meet quality expectationsReview and contribute to clinical study-related documents from a data management perspective (e.g., protocol) and approve DM-specific documents (e.g., Data Management Plan, Data Review Plan, CRF Completion Guidelines, etc.)Coordinate with Pharmacovigilance on adverse events (AE/SAE) reconciliation and work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed according to study timelinesLead the internal data review process in collaboration with study teams to ensure data qualityDefine the data listings needed to support the data review and ensure all identified issues are documented appropriately and resolvedEnsure archival and inspection readiness of all Data Management Trial Master (TMF) documentsProvide comprehensive data management expertise to project and study teams and train other personnel on data management-related activities, including eCRF and EDC system (iMedidata)Work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed within the specified study timelineParticipate in audits and inspections, and assist in performing functional assessments of data management CROs/vendorsPromote standardization, automation, process improvement and technical enhancement in CDM to improve efficiency and data quality Qualifications: Bachelor’s or Advanced degree in life sciences, healthcare, or a related field, or a combination of education and relevant experience; clinical research experience or education is a plus5+ years of progressive clinical data management experience within the pharmaceutical or biotechnology industry; experience in a small biotechnology company or similarly fast-paced, resource-limited environment is strongly preferredProving working knowledge of CDISC standards and hands-on experience reviewing or supporting SDTM mapping and related data-transformation activitiesExperience with EDC database development, edit-check specifications, sponsor UAT, database modifications, and database-lock activitiesAdvanced phase experience is preferred; experience supporting Phase 2 or later-stage clinical trials is preferredStrong hands-on experience overseeing data management CROs and external data vendors, including deliverable management, quality oversight, issue resolution, and managing timelinesDemonstrated ability to independently manage 2+ clinical programs with minimal supervision in a fast-paced environmentHands-on experience with clinical data review, including the identification, tracking, and resolution of data-quality issuesStrong organizational, analytical, problem-solving, and cross-functional communication skillsExperience managing local and central laboratory data, including data transfer specifications, data review, reconciliation, and issue resolutionOncology clinical trial experience is strongly preferred, including the review and management of tumor assessment and RECIST dataMedical coding and safety reconciliation experience is preferred, including MedDRA, WHO Drug Global, and SAE reconciliation Base Salary Range in Job Post: $130,000 USD - $170,000 USD Our mission is to bring transformative oncology therapies to patients. We built our core values from the employees up and each and every one of us is essential to achieving our mission. We are mission-focused, share a passion for science and creativity that help us innovate in all that we do. Our unique culture and community promotes authenticity, diversity of thought, and collaborative teamwork. Compass provides employees with a comprehensive and market-leading compensation and benefits package. Our compensation package includes a base salary, discretionary bonus, and meaningful equity participation for every employee. Our innovative benefits offerings support holistic employee health and wellness - from subsidized medical, dental and vision premiums to health reimbursement arrangement, flexible spending accounts, gym membership, employee assistance program, life insurance, and much more. We also offer 401(k) and Roth 401(k) programs with a 6% company match. Additional benefits include company parking, commuter reimbursement, and substantial vacation and leave policies, including summer Fridays, and a winter shut down week. Beyond traditional benefits, we invest in the growth and development of our teams and individuals through programs such as company-wide training, tuition and training reimbursement, recognition awards, and comprehensive performance management. With our Compass Culture Committee, we grow and preserve our culture through: events that build camaraderie and celebrate wins both large and small, diverse employee-driven initiatives, participation in charitable causes, and other programs that align with our values.