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Vacancy details
Vacancy description:
Job Code:
00272
Job Title:
Clinical Data Manager
Job Category:
IT & Data Management
Contract:
Permanent
Discipline:
Data Management, Clinical Data Coordinator
Country:
United States Of America
Location:
Massachusetts
Min experience:
4 years
Annual salary:
Negotiable
Apply by:
25 Jul 2008
If you have clinical data management experience then this is a great opportunity to develop your career with a prominent global CRO that serves the biopharmaceutical and medical device industries. The company, whose services range from full clinical trials management services throughout the clinical trials lifecycle right through FDA and product registration support requires a Clinical Data Manager to work under general supervision at their office in Southborough, MA.
JOB ROLE – Principal Duties and Activities include:
•Reviewing data.
•Assisting in database design and testing.
•Reviewing and understanding protocol.
•Designing CRFs and guidelines.
•Development and maintenance of the Data Management Plan, the Data Cleaning specifications and other Data Management documentation.
•Ensuring accurate tracking of all CRFs and DCFs and identifying any missing information.
•Designing and tests logic checks.
•Generating queries for missing or discrepant data.
•Utilizing tools/systems to code medical terms and medications.
•Reconciling clinical AEs with SAEs according to established guidelines.
•Working with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues.
•Providing input into the Department SOP's and process improvements.
•May participate in working groups, and the training of other CDM's.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
•Bachelors degree and 1+ years of clinical data management experience.
•Or, 4 + years of clinical data management experience in a CRO/pharmaceutical/biotech environment.
•Basic understanding of the clinical research development process and database design is essential.
•Good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies.
PERSONAL SKILLS & ATTRIBUTES:
•Good problem-solving skills and be detail-oriented.
•Excellent organizational skills with the ability to work to strict deadlines.
•Proficiency in operating computer applications and navigating the internet.
•Excellent verbal and written communications and interpersonal skills
•Ability to work independently
BENEFITS OF THE ROLE: There are fantastic career opportunities available with this prominent, global CRO for positions in the clinical development process. The company is an equal opportunities employer, offering competitive salaries and a range of excellent benefits including: paid vacation/holiday time off, health, dental and life insurances, 401(k) retirement saving and profit sharing plan, tuition reimbursement and a flex-time policy.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors.
KEY WORDS: Clinical Data Manager, Clinical Data Management, CDM, Data Manager, Data Management, Database Design, Database Testing, CRF Design, Protocol Review, CRF Tracking, Bachelors Degree, Clinical Research, Clinical Development, Drug Development, Physiology, Pharmacology, Clinical Studies, CRO
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