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 regulations
• Serve 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 SOPs
• Establish 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 requirements
• Provide a high level of expertise and guidance in data management to support clinical studies
• Lead 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 activities
• Lead 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 modifications
• Provide 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 delivery
• Collaborate with cross-functional partners to develop project and study timelines and maintain internal data management timelines, ensuring deliverables meet quality expectations
• Review 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 timelines
• Lead the internal data review process in collaboration with study teams to ensure data quality
• Define the data listings needed to support the data review and ensure all identified issues are documented appropriately and resolved
• Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents
• Provide 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 timeline
• Participate in audits and inspections, and assist in performing functional assessments of data management CROs/vendors
• Promote 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 plus
• 5+ 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 preferred
• Proving working knowledge of CDISC standards and hands-on experience reviewing or supporting SDTM mapping and related data-transformation activities
• Experience with EDC database development, edit-check specifications, sponsor UAT, database modifications, and database-lock activities
• Advanced phase experience is preferred; experience supporting Phase 2 or later-stage clinical trials is preferred
• Strong hands-on experience overseeing data management CROs and external data vendors, including deliverable management, quality oversight, issue resolution, and managing timelines
• Demonstrated ability to independently manage 2+ clinical programs with minimal supervision in a fast-paced environment
• Hands-on experience with clinical data review, including the identification, tracking, and resolution of data-quality issues
• Strong organizational, analytical, problem-solving, and cross-functional communication skills
• Experience managing local and central laboratory data, including data transfer specifications, data review, reconciliation, and issue resolution
• Oncology clinical trial experience is strongly preferred, including the review and management of tumor assessment and RECIST data
• Medical coding and safety reconciliation experience is preferred, including MedDRA, WHO Drug Global, and SAE reconciliation