What are the responsibilities and job description for the Director, Clinical Data Management position at BioSpace?
The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data Managers and Associates, to ensure to assure CROs and vendors are performing in compliance with Regeneron procedures. This is an exciting role that provides coaching, mentoring and performance management for all direct reports to help move Regeneron forward. Ensure that all data management (DM) activities are performed according to quality standards, regulatory requirements, and project budget from study start-up through archival in support of Regeneron key development programs. Works with Sr Director and Executive Director to set department goals and objectives and staffing levels and structure.
This Role May Be For You If
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)
$180,400.00 - $300,700.00
This Role May Be For You If
- Demonstrates expert knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
- Proven record of leading studies and study teams in a data processing environment.
- Demonstrates the ability to recommend innovation mastery or new process to meet objectives. Ability to draw from wide-ranging experience to resolve complex issues.
- Strong problem solving, project management, and communication skills required.
- Ability to work effectively with and empower virtual teams in matrix environment.
- Strong understanding of cross functional activities.
- Proven problem-solving skills.
- Strong ability to manage multiple and multifaceted tasks with enthusiasm, prioritize workload with attention to detail.
- Ability to adjust in a fast-paced environment.
- Work may be performed i: n hybrid (virtual and office) setting with minimal supervision.
- Mentor, coach, and guide managers.
- Education: Bachelors degree in mathematics, Science or a related field.
- Certified Clinical Data Manager (CCDM) experience.
- Minimum of 12 years of clinical data management experience in biotechnology, pharmaceutical or health related industry is required.
- Minimum of 5 years of people manager experience required.
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)
$180,400.00 - $300,700.00
Salary : $180,400 - $300,700
