The Manager, Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in specific therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Assists in the development of SOPs, Working Practice, Data Management Manual, and other data management standards.
In this role, a typical day might include the following:
Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.
Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality deliverables and within the budget. Mentor junior data mangers for skill set advancement. If required, leads and performs clinical data management tasks for studies.
Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP’s and work instructions in compliance with applicable regulations.
Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
This role may be for you if you have experience:
Supervising DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Coordinates with clinical project team for issue resolution.
Contributing to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
Ensuring adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
Establishing goals, expectations and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, managing training and leading the direct reports.
May direct the activities and hold accountable CRO/FSP data managers and/or data review teams.
To be considered for this opportunity you will need:
Bachelor Degree in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotech, pharmaceutical or health related industry.
Certified Clinical Data Manager (CCDM)
Previous people manager experience preferred but not required (May be responsible for 1 or more direct reports)
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.
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