Manager CDM Study Lead

Regeneron; Basking Ridge (NJ); On-site; USD 113,000 - 185,000; Full time

Job summary

A leading biotechnology company is looking for a Clinical Data Manager to lead data management activities across multiple clinical trials. The role involves overseeing data quality, managing CRO activities, and ensuring compliance with policies. Ideal candidates will have strong project management skills and extensive experience in clinical data management. Join us to contribute to innovative therapies and enjoy a comprehensive benefits package.

Benefits

Health Programs

Fitness Centers

Equity Awards

Bonuses

Paid Time Off

Qualifications

• 6+ years of progressive clinical data management experience.
• Study lead experience.

Responsibilities

• Oversee data management activities from study start-up through archiving.
• Support project teams and CROs with eCRF and database design.
• Lead data transfers, SAE/AE reconciliation, and coding activities.

Skills

Problem-solving

Project Management

Communication

Attention to Detail

Time Management

Education

Bachelor's Degree

Master's Degree

Job description

Join to apply for the Manager CDM Study Lead role at Regeneron

We are seeking a Clinical Data Manager to serve as the DM study lead and point of contact for clinical study teams and external partners (e.g., data vendors, CROs) across multiple trials (phases 1-3) within a Therapeutic Area. You will oversee data management activities from study start-up through archiving, ensuring timely completion within budget and compliance with policies and procedures.

As a Data Management Study Lead, your typical day may include:

• Providing expertise in data management to support clinical studies.
• Supporting project teams and CROs with eCRF and database design, data quality, and reporting.
• Supervising procedures for data quality review and database lock.
• Leading data transfers, SAE/AE reconciliation, and coding activities.
• Supporting database transfer, locking, and archiving; managing schedules across projects.
• Recommending process improvements for data management and flow.
• Overseeing small programs with limited studies.
• Ensuring consistency and compliance across SDMs, tracking milestones, and communicating updates.
• Overseeing CRO data management activities for assigned studies.

You may be considered for this role if you have:

• Strong problem-solving, project management, and communication skills.
• Ability to work effectively with virtual teams in a matrix environment.
• Understanding of cross-functional activities.
• Proven ability to manage multiple tasks with attention to detail.
• Effective time management skills.
• Excellent interpersonal and communication skills.
• Adaptability in a fast-paced environment.

To be considered, you must have:

• A Bachelor's or Master's Degree.
• 6+ years of progressive clinical data management experience.
• Study lead experience.

Apply now to take your first step towards living the Regeneron Way! We offer an inclusive culture and comprehensive benefits, including health programs, fitness centers, equity awards, bonuses, and paid time off.

Regeneron is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, nationality, age, disability, or other protected characteristics. We provide reasonable accommodations for disabilities or chronic illnesses.

Salary Range (annual): $113,100 - $184,700

Additional Information:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analysis, IT
• Industry: Biotechnology