Senior Clinical Data Management
Proclinical is currently recruiting for a Senior Clinical Data Manager for a pharmaceutical company located in Boston, MA. Successful candidate will be responsible for performing Data Management activities that support the client's development projects worldwide.
- Represent Data Management on the Study Execution Team for assigned studies.
- Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO/vendor counterparts.
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Lead the development of data edit check specifications and data listings.
- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members.
- Develop or lead the development of the Data Management Plan for a clinical study.
- Perform reconciliation of header data from external data sources against the clinical database.
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines.
- Lead database upgrades/migrations including performing User Acceptance Testing.
- Perform/ Oversee database lock and freeze activities per company SOPs.
- Participate in regular team meetings and provide input when appropriate.
- Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents.
- Assist with the training of new employees and/or contractors.
Skills and Requirements:
- BA/BS, preferably in the scientific/healthcare field.
- 5-10+ years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, 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 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.
- Possesses strong English language written and verbal communication skills.
- Able to travel to off-site meetings or training seminars as needed.
- 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 is desirable.
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 Junis Citozi at (+1) 929-388-1650 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.
£0.00 - £50000.00 per annum
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