Associate Manager CDM Study Lead

Regeneron Pharmaceuticals; Basking Ridge (NJ); On-site; USD 96,000 - 158,000; Full time

Job summary

Join a forward-thinking company as an Associate Manager in Clinical Data Management, where you will collaborate with diverse teams to ensure compliance with regulations and study protocols. In this dynamic role, you will lead data management activities, prepare Data Management Plans, and oversee data quality, all while fostering an inclusive culture that values your contributions. This position offers an exciting opportunity to impact clinical studies and advance your career in a supportive environment with comprehensive benefits.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• 6+ years of clinical data management experience in biotech or pharma.
• Strong understanding of regulations like 21 CFR Part 11 and ICH-GCP.

Responsibilities

• Lead data management activities from study start-up to archiving.
• Oversee data quality review procedures and manage data transfers.

Skills

Interpersonal Skills

Communication Skills

Problem Solving

Project Management

Time Management

Education

Bachelor's degree in Mathematics

Certified Clinical Data Manager (CCDM)

Job description

Associate Manager, Clinical Data Management (CDM) collaborates with vendor Project Managers and Clinical Data Managers to ensure Data Management functions comply with regulations and study protocols. This role involves preparing the Data Management Plan (DMP) according to company SOPs and Regeneron's data standards, leading data management activities for assigned studies.

As an Associate Manager, a typical day might include the following:

• Serve as the primary DM study lead for clinical study teams and external partners for small or non-complex studies, or support larger studies within a given TA. Oversee all DM activities from study start-up to archiving.

• Provide expertise in data management, support eCRF and database design, and ensure data quality.

• Oversee data quality review procedures, data acceptance, and manage data transfers with CROs.

• Document and oversee CRO data management activities, ensuring adherence to SOPs and identifying data quality issues.

• Review and approve study documentation, including DMP, CRF, and validation specifications.

• Maintain eTMF documentation and perform quality reviews to ensure inspection readiness.

• Lead data management deliverables, ensuring timelines align with business needs and objectives.

• Monitor data quality, assess data issue progress, and propose risk mitigations.

• May act as a Subject Matter Expert (SME) for specific topics and provide training.

• Represent DM in study-level forums and meetings.

This role might be for you if you have:

• Excellent interpersonal, oral, and written communication skills.

• Effective time management and ability to adapt in a fast-paced environment.

• Strong understanding of cross-functional activities and proven problem-solving capabilities.

To be considered for this role, you must have:

• Bachelor's degree in Mathematics, Science, or related field.

• Certified Clinical Data Manager (CCDM) preferred.

• Minimum of 6+ years of clinical data management experience in biotechnology, pharmaceutical, or health-related industry.

• Strong understanding of applicable regulations, including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards.

• Proven leadership in data processing environments and robust knowledge of DM processes.

• Strong problem-solving, project management, and communication skills.

• Ability to work effectively in a virtual team environment and manage multiple tasks.

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.

Salary Range (annually)

$96,700.00 - $157,700.00