The Program Data Management Lead will provide leadership and overall strategic management of Programs in Clinical Data Management (CDM).
This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, teamwork partners and clinical study personnel for clinical research project and department initiatives. The PDML may be responsible for line management of clinical data management staff, which would include responsibility for staff recruitment, development, coaching, mentoring, and performance management.
As an Associate Director, CDM Lead, a typical day might include:
Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM).
Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide CDM program level updates to stakeholders as requested.
Review of plans and provision of CDM expertise during protocol design, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CDM. Ensure use of standards for data collection and cleaning.
Ensure quality deliverables adhere to timelines and accountable for ensuring consistency of process and approaches across clinical study deliverables.
Oversees program level deliverable timelines ensuring proper resources are in place and monitoring overlapping deliverables.
Oversees CDM study budgets within a program ensures review of initial study budget and manages the budget through the lifecycle of the program by communicating changes as appropriate.
Acts as point of contact for clinical program and study level escalation.
Reviews key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.
Provides proactive creation and implementation of risk mitigation strategies.
Provides innovative and flexible data management solutions and options to the cross functional teams when faced with challenges.
Leads all aspects of Quality Events, CAPAs, SSN and process deviations across the program.
Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
Attends and represents CDM for a program(s) at review committee meetings as appropriate.
Participates in CRO governance meetings as needed for clinical program(s)
Participates in Joint Meetings with Collaborative Partners at the study level and program level.
Ensures inspection readiness throughout the clinical program lifecycle, coordinates and manages CDM activities during Regulatory Authority Inspections.
May be responsible for direct supervision of CDM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
To be considered for this opportunity, you must have the following:
Bachelor’s degree in Mathematics, Science, or a related field.
Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical or health related industry is required.
5 years of people management experience is preferred.
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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