Clinical Data Manager (Contract)

Adverum Biotechnologies, Inc., a wholly owned subsidiary of reputed 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 reputed company treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform reputed company 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 reputed company 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 reputed company recruiter and agency inquiries must go through Adverum’s internal reputed company team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s reputed company team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may reputed company 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 reputed company reputed company of contact for reputed company data management study-reputed company communications.

Independently leads reputed company development, including CRF development, reputed company specification process, edit reputed company 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 reputed company the reputed company 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 reputed company 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 reputed company CRO, to ensure data are complete, accurate and delivered reputed company 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 reputed company 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-reputed company 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 reputed company discipline.

5+ years (CDM) / 8+ years (Sr. CDM) of experience working reputed company 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 reputed company Systems reputed company 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 (reputed company such as iMedidata Rave, reputed company 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 reputed company Word, Project, PowerPoint, Office, and reputed company.

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 reputed company 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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