Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) BS in a Biomedical Science or equivalent
2) MS with minimum 4 years of relevant industry experience
3) Minimum 6+ years of relevant experience along with clinical background/experience in clinical data management in a CRO or bio/pharmaceutical setting
4) Experience in relational database design
5) General knowledge of FDA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA
6) Excellent communication, problem solving and people/project leadership skills
7) Excellent verbal and written communication skills and interpersonal skills
Job Description
Print Job Description
Partial Job Description 1) Work collaboratively with CRA, statistical programmer, biostatistician and other clinical, global drug safety, regulatory and project management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting 2) Ensure completeness, correctness and consistency of clinical data and data structure 3) Ensure effective communication with vendors with a general understanding and expectation in terms of study timelines and milestones 4) Lead the design and implementation of clinical data management process with CRO, including data entry, data quality checking, data transfer, reporting, backup and recovery 5) Lead the design of CRF/eCRF for sound and thorough data collection through the regulatory approval process 6) Assist in planning and implementation of the data management portions of clinical research projects 7) Review study protocols and assist site coordinators, investigators and field clinical staff in collecting data to meet the protocol requirements in a timely manner 8) Identify, track and resolve non-routine queries 9) Utilize reports to track study progress and ensure timeliness and quality expectations are met
