Regeneron Pharmaceuticals, Inc

Manager, Clinical Data Manager Study Lead

Regeneron Pharmaceuticals, Inc • $114K — $187K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent experience in Mathematics, Science, or related field.
  • 7+ years of clinical data management experience in biotech, pharmaceutical, or health industries.
  • Experience with electronic case report form (eCRF) design and database management.
  • Strong understanding of data quality review and compliance protocols.
  • Proven ability to oversee and manage multiple complex studies simultaneously.

Responsibilities

  • Lead the data management (DM) efforts for multiple clinical studies across various stages.
  • Serve as the primary contact for clinical teams and external partners, acting as the bridge for data management tasks.
  • Ensure effective communication regarding data quality and project timelines with team members and CROs.
  • Oversee data transfers, SAE/AE reconciliation, and coding processes in collaboration with third-party sources.
  • Prepare and recommend improvements for data management processes and workflows.
  • Conduct regular status updates and provide metrics to the clinical study team (CST).
  • Document oversight activities and ensure compliance with SOPs for all assigned studies.

Benefits

  • Remote work flexibility with a 25% travel requirement.
  • Opportunities for professional development and training.
  • Access to a supportive network of data management professionals.
  • Participation in innovative projects within the biotech sector.
  • Involvement in improving data management processes and standards.
Full Job Description

Build our future together:

The Manager Clinical Data Manager Study Lead , provides oversight of lead Data Manager(s) on assigned clinical data management studies in specific therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Assists in the development of SOPs, Working Practice, Data Management Plan, and other data management standards.


When & where:
  • Location: Remote
  • Travel percentage: 25%

Discover your role:

Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more complex studies within a given TA. Oversee all DM activities across all stages of the trial from study start-up through archiving. To include but not limited to 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.
  • Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
  • Manage 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. Manage scheduling and time constrains across multiple projects.
  • Prepare recommendations for new or improved processes for data management and data flow.
  • Perform & document the oversight of CRO data management activities for assigned studies:
  • Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs.
  • Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
  • Document DM sponsor oversight activities from protocol review through study close-out.

Review and approve study documentation for assigned studies, (including, but not limited to):

  • Data Management Plan or equivalent (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data)
  • Case Report Form and Completion Guidelines
  • Validation specifications and data transfer specifications

This role requires:
  • Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
  • Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness
  • Review (IRR) compliance
  • Follow through on gaps until resolution, escalating as necessary.
  • Lead/oversee all data management deliverables for assigned studies:
  • 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.
  • Identify risks, propose mitigations, proactively escalate operational or DM vendor or DM CRO issues.
  • May provide limited program level support for a small program with limited number of studies

Salary Range (annually)

$114,800.00 - $187,400.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Regeneron Pharmaceuticals, Inc

More Pharmaceuticals & Biotech Jobs

Find similar Manager, Clinical Data Manager Study Lead jobs:

NationwideRemote