The Principal Clinical Data Manager is responsible for the oversight and management of Imara assigned studies throughout the full study lifecycle, from study start-up through database archive. This includes oversight and collaboration with the CRO(s) and cross-functional teams for protocol review, database design specifications, validation, maintenance, and data cleaning. The Principal Clinical Data Manager at Imara ensures quality standards and deliverables by applying Good Clinical Data Management Practices (GCDMP) and adhering to ICH GCP guidelines. This position reports into the Director, Data Management.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Oversee all data management activities for assigned studies performed by CROs
- Function as study DM liaison with cross-functional team members, both internal and external, to ensure quality on-time data management deliverables.
- Oversight of CROs/vendors to ensure efficiency, quality, and consistency for all data management deliverables across assigned study or program
- Represent Data Management at assigned study team meetings including Kick off meetings, lessons learned meetings and close-out meetings.
- Oversee and collaborate with CROs in development of Data Management documents including DMPs, eCRF Completion Guidelines, eCRFs, DTA/DTS
- Participate in User Acceptance Testing (UAT) for database, edit check specifications.
- Oversee and perform data review for overall consistency, data trends and issues and collaborate with CRO on development and implementation on remediation plan(s) and timelines
- Oversee vendor data reconciliation (e.g., IVRS, laboratory data, SAE Reconciliation) within the clinical database(s) to include QC of queries/query responses, manual listings, external data reconciliation, metrics, and custom reports as required throughout the study
- Track data management activities and issues and ensure follow-up/completion to resolution.
- May act as Subject Matter Expert in assigned area(s).
- Assist in the creation and review of Data Management SOPs, WIs, and training materials.
- Mentor junior level staff and peers on all associated tasks within a study.
- Maintain internal data management study documentation to audit ready status
- Perform other duties as requested by management
- BS or MS, preferably in the scientific/healthcare or related field
EXPERIENCE, KNOWLEDGE, SKILLS, AND ABILITIES
- 7+ years Lead Clinical Data Management experience in Pharmaceutical or Biotech industry
- Comfortable in a fast-paced, small company environment with ability to manage a variety of projects simultaneously Must be a self-starter and function well under minimal supervision
- High attention to detail including proven ability to manage multiple, competing priorities
- Working knowledge of GCP, FDA, ICH, CDISC, CDASH and GCDMP
- Detail oriented, with strong prioritization, critical thinking, planning and organizational skills
- Ability to communicate data management standards, developments, and challenges in an accurate, concise, and consistent manner to both internal and external stakeholders
- Excellent verbal and written communication skills
- Proficient working knowledge of EDC platforms(Medidata Rave, Oracle Clinical Inform, Axiom Fusion) and various IVRS/IRT solutions
- Experience/Knowledgeable about clinical data management outsourcing with full service global CROs and niche providers
Imara is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, Imara complies with applicable state and local laws governing nondiscrimination in employment.