As a Senior Clinical Data Manager you 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 within a given Therapeutic Area (TA). 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.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.
This role may be for you if:
- Candidates should have working understanding of all applicable regulations including; 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collection.
- Must have consistent record of leading clinical studies and clinical study teams in a data processing environment and demonstrate robust knowledge of Data Management processes and industry standard methodologies, drawing from wide-ranging experience to resolve complex issues.
- Strong problem solving, project management, and presentation skills essential to the role are required. Must possess ability to work effectively with and motivate virtual teams in matrix environment and solid understanding of cross-functional activities.
- Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.
To be considered you should have Bachelor degree in Mathematics, Science or a related field, minimum of 5 or more years of clinical data management experience in biotech, pharmaceutical or health related industry is required.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.