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Associate Director
3 months ago
Associate Director / Director, Clinical Data Management
Status: Exempt
Type: Full-Time
Reports to: Head of Biometrics
Summary
The Associate Director / Director of Clinical Data Management, working closely with the broader clinical cross-functional team, will serve as a key hands-on leader responsible for overseeing the data management function within the Biometrics organization. This key role will be responsible for overseeing the strategic direction, management, and execution of clinical data management activities across our clinical trials. The ideal candidate will have a proven track record of success in clinical data management, strong leadership skills, and a deep understanding of regulatory requirements and industry standards.
Essential Functions
The Associate Director / Director of Clinical Data Management is an exceptional hands-on, highly detail-oriented, innovative, and collaborative leader that possesses the ability to work closely with cross functional colleagues to ensure effective, timely, high-quality data support for clinical development deliverables across the company’s portfolio.
Key Responsibilities:
- Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Statistical Programming, and Regulatory Affairs to ensure data management activities support overall clinical trial objectives.
- Manage the data management timelines, budgets, and resources to ensure the successful and timely delivery of data.
- Develop and implement data management strategies that align with project goals and regulatory requirements.
- Oversee the planning, design, and execution of data management processes, including data collection, cleaning, and analysis.
- Lead and mentor junior clinical data management team members, fostering a collaborative and high-performance environment.
- Ensure data management practices comply with FDA, EMEA, and other relevant regulatory requirements and industry standards.
- Oversee the preparation and submission of data management documentation for regulatory submissions and audits.
- Ensures all data management work is performed consistent with quality in accordance with Good Clinical Practices (GCP)
- Identify opportunities for process improvements and implement best practices in clinical data management.
- Evaluate and leverage new technologies and tools to enhance data management efficiency and effectiveness.
- Oversee relationships with external data management vendors and ensure their deliverables meet quality and timeline expectations.
- Manage contracts and performance metrics for outsourced data management services.
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines
- Acts as clinical data management subject matter expert for internal and external stakeholders.
Skills and Competencies
- Minimum of 5 years of experience in clinical data management.
- Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- Profound knowledge of CDISC standards (SDTM/ADAM) and data transfer specifications for third party vendors and third-party data analyses
- In depth knowledge of clinical trial design, data management processes, regulatory requirements, and clinical trial data standards
- Strong leadership, communication, and interpersonal skills.
- Proficiency in data management systems and software, such as EDC, CDMS, and statistical software packages.
- Ability to work effectively in a fast-paced and dynamic environment.
Supervisory Responsibility
This position may provide supervision responsibility.
Work Environment
This job operates in a professional laboratory and office.
Physical Demands
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to see, talk, and hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Position Type/Expected Hours of Work
This position is full-time, and is expected to be on-site; Monday through Friday.
Travel
Infrequent travel is expected (5%).
AAP/EEO Statement
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Candidates only; please do not contact if you are a recruiter.