Lead Clinical Data Manager
Proclinical is currently recruiting for a Lead Clinical Data Manager with a global biotechnology company located in Rockville, MD. Successful candidate will be responsible for performing/overseeing outsourced Data Management activities that supports clinical trials worldwide.
- Manage and monitor the progress of data management activities with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
- Represent Data Management during internal IMC calls or meetings.
- Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs).
- Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors while designing eCRFs, creating the annotated eCRF, and CRF completion guidelines.
- Lead the development of data edit check specifications and data listings.
- Coordinate the testing of Electronic Data Capture (EDC) systems according to company standards.
- Develop or lead the development of the Data Management Plan for a clinical study.
- Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and third-party data transfer specs
- May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
- Oversee reconciliation of third-party data from external data sources against the clinical database.
- Oversee Serious Adverse Event reconciliation activities according to SOPs and guidelines.
- Lead database upgrades/migrations including performing User Acceptance Testing, as required.
- Oversee, with the CTM, maintenance of data management files.
- Assist in the database lock and freeze activities per SOPs and timelines.
- Participate in regular team meetings and provide input when appropriate.
- Ability to run standard and Ad-hoc reports from clinical study databases as needed by study teams or medical monitors.
Skills and Requirements:
- BA/BS, preferably in the scientific/healthcare field.
- At least 5 years of directly relevant work experience.
- Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, including study lead experience.
- Has good project management skills and a proven ability to multitask.
- Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems. Experience with InForm and Rave is preferred.
- Written and oral communication - Writing and speaking clearly to share thoughts and information concisely and appropriately.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.