Clinical Data Manager II

Compass Therapeutics • Boston, MA

1d • Onsite

About The Position

Compass Therapeutics is seeking a highly motivated, hands-on Clinical Data Manager II to support its oncology clinical programs. The role oversees clinical data management across CROs and external vendors, helping ensure high-quality clinical trial data from study start-up through database lock. The successful candidate will work in a fast-paced, collaborative environment and report to the Director of Biometrics. The position is onsite four days per week in Brighton, Massachusetts.

The Clinical Data Manager II provides data management expertise to project and study teams, oversees CRO and vendor deliverables, and leads clinical data management processes, database activities, data review, and inspection readiness. The role also works with cross-functional partners on timelines, study documents, safety reconciliation, medical coding, audits, and process improvement.

Requirements

• Bachelor’s or advanced degree in life sciences, healthcare, or a related field, or a combination of education and relevant experience.
• Five or more years of progressive clinical data management experience in the pharmaceutical or biotechnology industry.
• 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.
• Hands-on experience overseeing clinical data management CROs and external data vendors, including deliverables, quality oversight, issue resolution, and timelines.
• Ability to independently manage two or more clinical programs with minimal supervision.
• Hands-on clinical data review experience, including identification, tracking, and resolution of data-quality issues.
• Experience managing local and central laboratory data, including transfer specifications, data review, reconciliation, and issue resolution.
• Strong organizational, analytical, problem-solving, and cross-functional communication skills.

Nice To Haves

• Clinical research experience or education.
• Experience in a small biotechnology company or similarly fast-paced, resource-limited environment.
• Advanced-phase experience, including support for Phase 2 or later-stage clinical trials.
• Oncology clinical trial experience, including review and management of tumor assessment and RECIST data.
• Medical coding and safety reconciliation experience, including MedDRA, WHO Drug Global, and SAE reconciliation.

Responsibilities

• Keep clinical data management goals on track to meet milestones, timelines, quality and cost expectations, and applicable regulations.
• Serve as the primary contact overseeing data management across multiple CRO partners and external vendors, including deliverables, workflows, quality, issue resolution, and compliance.
• Establish data transfer guidelines and agreements; oversee receipt, integration, validation, reconciliation, review, and transfer of external clinical data.
• Provide data management expertise and guidance to support clinical studies and project and study teams.
• Lead the establishment and optimization of clinical data management processes, including authoring, reviewing, implementing, and maintaining SOPs and Work Instructions.
• 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 for database builds and modifications.
• Collaborate with cross-functional partners to develop project and study timelines and maintain internal data management timelines.
• Review and contribute to clinical study documents from a data management perspective and approve data management-specific documents, including Data Management Plans, Data Review Plans, and CRF Completion Guidelines.
• Coordinate adverse event and serious adverse event reconciliation with Pharmacovigilance and work with medical coding teams to meet study timelines.
• Lead internal data review with study teams, define data listings needed for review, and ensure identified issues are documented and resolved.
• Ensure archival and inspection readiness of Data Management Trial Master File documents.
• Train personnel on data management activities, including eCRF and the iMedidata EDC system.
• Participate in audits and inspections and assist with functional assessments of data management CROs and vendors.
• Promote standardization, automation, process improvement, and technical enhancements in clinical data management.

Benefits

• Base salary, discretionary bonus, and meaningful equity participation.
• Subsidized medical, dental, and vision premiums.
• Health reimbursement arrangement and flexible spending accounts.
• Gym membership and employee assistance program.
• Life insurance.
• 401(k) and Roth 401(k) programs with a 6% company match.
• Company parking and commuter reimbursement.
• Vacation and leave policies, including summer Fridays and a winter shutdown week.
• Company-wide training and tuition and training reimbursement.
• Recognition awards and comprehensive performance management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level