Clinical Data Manager II

Compass Therapeutics•Boston, MA

2d•$130,000 - $170,000•Onsite

About The Position

Compass Therapeutics is an oncology-focused biopharmaceutical company developing antibody-based therapeutics. The Biometrics team is seeking a hands-on Clinical Data Manager II to support oncology clinical programs. The role oversees CROs and external data, supports high-quality clinical trial data from study start-up through database lock, and provides data management expertise to project and study teams. The position reports to the Director of Biometrics and is onsite four days per week at the company’s office in Brighton, Massachusetts. The Clinical Data Manager II will manage clinical data activities across multiple programs, oversee CRO and vendor deliverables, and ensure compliance with protocols, internal procedures, GCP, regulatory guidelines, company policies, and SOPs. The role leads database design and sponsor UAT, external data integration and validation, internal data review, documentation, and process improvement. It also works closely with cross-functional teams, Pharmacovigilance, medical coding partners, and study teams to support timely, high-quality, and cost-effective clinical trial delivery. Compass offers a base salary of $130,000–$170,000, discretionary bonus, and equity participation. Benefits include subsidized medical, dental, and vision premiums; a health reimbursement arrangement; flexible spending accounts; gym membership; employee assistance program; life insurance; 401(k) and Roth 401(k) with a 6% company match; company parking; commuter reimbursement; vacation and leave policies, including summer Fridays and a winter shutdown week; and tuition and training reimbursement. The company also provides company-wide training, recognition awards, and performance management programs.

Requirements

Bachelor’s or advanced degree in life sciences, healthcare, or a related field, or a combination of education and relevant experience.
At least 5 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.
Experience overseeing data management CROs and external data vendors, including deliverable management, quality oversight, issue resolution, and timeline management.
Ability to independently manage two or more clinical programs with minimal supervision in a fast-paced environment.
Hands-on clinical data review experience, including identifying, tracking, and resolving data-quality issues.
Experience managing local and central laboratory data, including transfer specifications, 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 or experience supporting 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

Ensure clinical data management goals and milestones are met within timelines and in accordance with study expectations for quality, time, cost, and applicable regulations.
Serve as the primary contact overseeing data management across CRO partners and external vendors, including deliverables, workflows, quality, issue resolution, and compliance.
Establish data transfer guidelines and agreements with CROs and external data vendors; oversee receipt, integration, validation, reconciliation, review, and transfer of external clinical data.
Provide data management expertise and guidance in support of clinical studies.
Lead the establishment and optimization of CDM 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 the design and creation of clinical trial study databases and perform sponsor UAT for database builds and modifications.
Advise clinical project and study teams on study-specific data management processes to support high-quality, timely, and cost-effective delivery.
Collaborate with cross-functional partners to develop project and study timelines and maintain internal data management timelines.
Review clinical study documents from a data management perspective and approve data management documents, such as Data Management Plans, Data Review Plans, and CRF Completion Guidelines.
Coordinate adverse event and serious adverse event reconciliation with Pharmacovigilance.
Work with medical coding partners on MedDRA and WHO Drug Global coding to meet study timelines.
Lead internal data review with study teams and define listings needed to support review.
Ensure data issues are documented and resolved and that Data Management TMF documents are archived and inspection-ready.
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 enhancement in CDM.

Benefits

Discretionary bonus and meaningful equity participation.
Subsidized medical, dental, and vision premiums.
Health reimbursement arrangement.
Flexible spending accounts.
Gym membership.
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.
Tuition and training reimbursement.
Company-wide training, recognition awards, and comprehensive performance management.