The Senior Manager Data Management provides Clinical Data Management oversight to Data Managers and Associates, to ensure CROs and vendors are performing in compliance with Regeneron procedures. Ensure consistent processes across all studies for multiple projects or TA. Provides coaching, mentoring and performance management for all direct reports. Provides direction and oversees all data management (DM) activities are performed according to quality standards, regulatory requirements, and project budget from study start-up through archival in support of Regeneron key development programs.
As a Senior Manager, Clinical Data Management, a typical day might include:
Responsible for direct DM reports manages escalations from and about their direct report, provides feedback communication to direct reports (performance management, development, and growth opportunities) Responsible for resource management for assigned TAs, projects and direct reports Responsible for ensuring direct and indirect reports follows policies and procedures, SOPs, and work instructions in compliance with applicable regulations. Oversee multiple programs - Accountable for providing comprehensive program level oversight of Managers/CDMs to ensure Consistency and compliance of program level standards Track milestones/deliverables Escalate and follow to resolution as necessary Communicate program level updates to SDMs Interact cross-functionally and provide project leadership for SDMs within the program and for direct reports For Direct reports, verify oversight of data management deliverables. Ensure deliverable timelines are developed according to the business need and program objectives. Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval. Ensure regular status updates with metrics are provided to CST. Provide program level input to & monitor deliverable timelines. Monitor data quality and assess progress of data issue remediation on an ongoing basis. Ensure risks are identified, mitigations are proposed, and DM vendor or DM CRO issues are proactively escalated. For assigned Program(s), verify oversight of data management deliverables May fulfill the SME role for 1 or more topics. Develop and deliver SME specific training Provide ongoing support for the DM organization & key stakeholders (as applicable). May lead a DM or cross-functional initiative providing deep expertise in DM processes May represent DM at program level forums; Regular check-in meetings (weekly/bi-weekly) to monitor status. Mentor, coach, and guide managers May direct the activities and hold accountable CRO/FSP data managers and/or data review teams
This role might be for you if you:
Demonstrates sophisticated knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections. Demonstrates thorough 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 multifaceted experience to resolve complex issues. Strong analytical, project management, written and interpersonal skills required. Ability to work optimally with and motivate virtual teams in matrix environment Strong understanding of cross functional activities Proven problem-solving skills Strong ability to manage multiple and multifaceted tasks with enthusiasm, prioritize workload with attention to detail Effective time management to meet objectives Excellent interpersonal, oral, and written communication skills Ability to adjust in a fast-paced environment.
To be considered for this role, you must meet the following qualifications:
Education: Bachelors degree in Mathematics, Science or a related field. Certified Clinical Data Manager (CCDM)
Experience: Minimum of 8 years of clinical data management experience in biotechnology, pharmaceutical or health related industry is required. Minimum of 3 years of people manager experience required.
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.
Salary Range (annually)
$132,400.00 - $216,000.00