We are looking for a Clinical Data Manager who will serve as the DM study lead and point of contact for clinical study teams and external partners, (e.g, external data vendors and CROs) for multiple trials (phases 1-3) within a given Therapeutic Area (TA). You will oversee 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 contributes to department-level goals to ensure timely completion within project budget guidelines and adhering to all applicable policies and procedures.
As a Clinical Data Manager, 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.
Supervise 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
May oversee small program with limited number of studies
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
Perform & document the oversight of CRO data management activities for assigned studies.
This role might be for you if you have:
Strong problem solving, project management, and communication skills required.
Ability to work effectively with and motivate virtual teams in matrix environment.
Strong understanding of cross functional activities.
Proven problem-solving skills.
Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail.
Effective time management to meet objectives.
Excellent interpersonal, verbal, and written communication skills.
Ability to adjust in a fast-paced environment.
To be considered for this role, you must have a Bachelor degree in Mathematics, Science or a related field, minimum of 10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry is required. Certified Clinical Data Manager (CCDM). Demonstrated broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
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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.
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Indian Occupation
YEPP - Your External People Partner
