Senior Data Manager

Full job description

The Senior Clinical Data Manager will serve as the DM study lead and point of contact for clinical study teams and external partners for multiple trials within a given Therapeutic Area (TA). Lead all aspects of DM activities across all stages of the trial from study start-up through archiving to achieve data management results within the assigned drug assets and gives to department-level goals to ensure timely completion within project budget guidelines and adhering to all applicable policies and procedures.

A typical day might include the following:
Provide a high level of expertise in data management to support clinical studies.

Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.

Own the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.

Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.

Support the transfer, locking, and archiving of study databases. Lead scheduling and time constrains across multiple projects.

Prepare recommendations for new or improved processes for data management and data flow.

This role may be for you if:
Candidates should have working understanding of all applicable regulations including; 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collection.

Must have proven record of leading clinical studies in a data processing environment and demonstrate robust knowledge of Data Management processes and industry standard methodologies, drawing from sophisticated experience to resolve issues.

Strong problem solving, project management, and presentation skills crucial to the role are required. Must possess ability to work efficiently with and empower virtual teams in matrix environment and shown understanding of cross-functional activities.

Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.

To be considered for this opportunity you must have:
A Bachelors degree in Mathematics, Science or a related field with a minimum of 5+ of clinical data management experience in biotech, pharmaceutical or health related industry required.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.