The Clinical Data Manager oversees data management activities across clinical studies, ensuring data compliance and quality from start-up to closure, while managing CRO vendors and leading the data management team.
Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
The Clinical Data Manager (CDM) is responsible for data management activities across one or more studies from study start-up through study closure to ensure completion per established project team goals and objectives, including oversight of the CRO DM Vendor, if the project is outsourced. The CDM / Senior CDM will report to the Head of Clinical Data Management and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.
This is a 6-12 month contract.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
What you'll do:
- Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices.
- Independently serves as the lead point of contact for all data management study-related communications.
- Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
- Reviews and assists in the development of study documents drafted by CROs such as Data Management Plans, Data Validation Specifications, eCRF Completion Guidelines, Data Review Plans, Data Transfer Agreements, and other cross-functional study documents that may require data management input.
- Ensures the quality of clinical data within the EDC and other databases through regular data review and external data reconciliation processes and communicates any outstanding issues to the cross-functional teams.
- Monitors and tracks the quality of all data management deliverables.
- Leads data deliverables including snapshots for DMC, investor relations, publications, etc., and interim and final database locks, in collaboration with the CRO DM Vendor.
- Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
- Leads and facilitates Data Review Meetings with the cross-functional team, presenting metrics, trends, risks, and or issues.
- Actively participates in team meetings – DM or cross-functional.
- Coordinates transfers of SAS datasets or external data transfers from CROs.
- Support TFL reviews, yearly regulatory submission requirements, compilation of CSRs, etc.
- Responsible for TMF maintenance of data management-related study documents.
- Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
About You:
- Bachelor's degree or equivalent in life science, computer science, or related discipline.
- 5+ years (CDM) / 8+ years (Sr. CDM) of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II and/or III studies, from start-up through closure.
- Demonstrated proficiency in various EDC Systems within the last 3 years.
- Demonstrated proficiency in data management processes, clinical trial processes, and applicable regulatory requirements.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Experience with web-based Electronic Data Capture (EDC such as iMedidata Rave, Oracle InForm, etc.), clinical data management systems - eCOA, IRT, and industry wide thesauri, such as MedDRA and WHO Drug.
- Experience in managing CRO Data Management vendors.
- Knowledge of industry standards (CDISC, CDASH, SDTM, etc.).
- Demonstrated proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel.
- Excellent organizational skills and attention to detail.
- Effective communication (verbal/written) and interpersonal skills.
- Able to set priorities and juggle multiple projects and demands.
- Able to think critically and independently and be a proactive problem-solver.
- Able to lead and work independently while exercising initiative, flexibility, and sound judgment.
- Comfortable working in a fast-paced environment with different levels of the company including senior level management.
- Proven ability to work both independently and in a team setting.
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