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Principal Clinical Data Manager I
3 months ago
This position is based out of our Uxbridge, UK office with an expectation to be on-site 3 nonconsecutive days.
In this role, a typical day might include the following:
Serves as primary DM contact to clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
Accountable for providing comprehensive program level oversight of SDMs to ensure consistency and compliance of
program level standards, track milestones/deliverables, escalate and follow to resolution as necessary, and
communicate program level updates to SDMs
• Interact cross-functionally and provide project leadership for SDMs within the program and for direct reports
• Perform & document the oversight of CRO data management activities for assigned studies.
Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications for assigned projects.
This role may be for you if you have experience:
Demonstrating broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and
CDISC standards for data collections.
• Proven record of leading studies and study teams in a data processing environment
• Demonstrates advanced knowledge of Data Management processes and industry best practices. Demonstrates the
ability to recommend best practices or new process to meet objectives. Ability to draw from wide-ranging
experience to resolve complex issues
To be considered for this opportunity you will need:
Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 8 or more years of clinical data management experience
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels
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.
