Clinical Data Manager/Senior
The Clinical Data Manager / Senior 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.
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.
About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation