Clinical Data Management Lead
2 weeks ago
The Program Clinical Data Management Lead is responsible for 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, collaboration partners and clinical study personnel for clinical research project and department initiatives.
Key Responsibilities
- 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 collaborators 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 standard methodologies within CDM. Ensure use of standards for data collection and cleaning.
- Ensure quality results, implement timelines and accountable for ensuring consistency of process and approaches across clinical study results.
- Leads all aspects of program level result timelines ensuring proper resources are in place and supervising overlapping deliverables.
- Oversees CDM study budgets within a program ensures review of initial study budget and handles the budget through the lifecycle of the program by communicating changes as appropriate
Requirements
- 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.
- Manages 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
- 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
Education and Experience
- 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.
About Regeneron
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)
$151,800.00 - $247,800.00
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