Mantell Associates are thrilled to have partnered with a renowned, global CRO who partner with a huge variety of pharmaceutical and biotechnology sponsors across phases I through IV. They are looking for several additions to their US Clinical Data Management department, to support their client's clinical trial design and analysis, including a Senior Data Team Lead.

Senior Data Team Lead - Responsibilities:

1. Data Management Leadership: Provide leadership and guidance to the data management team throughout the lifecycle of clinical trials. Supervise and mentor junior data management staff to ensure high-quality deliverables.

2. Clinical Data Oversight: Oversee the collection, validation, and cleaning of clinical trial data to ensure accuracy, completeness, and consistency. Develop and implement data management plans and procedures for each study.

3. Database Development and Maintenance: Collaborate with cross-functional teams to design, build, and validate clinical trial databases using industry-standard tools and systems. Ensure database structures are optimized for data collection and analysis.

4. Quality Control and Assurance: Implement quality control procedures to identify and resolve data discrepancies and inconsistencies. Conduct regular data reviews and audits to ensure compliance with regulatory requirements and company standards.

5. Regulatory Compliance: Stay abreast of regulatory guidelines and requirements related to clinical data management (e.g., FDA, ICH, GCP). Ensure that all data management activities adhere to regulatory standards and are conducted in accordance with applicable regulations.

6. Risk Management: Identify potential risks and issues related to data management activities and develop mitigation strategies. Proactively address any data-related issues to minimize impact on study timelines and outcomes.

7. Vendor Management: Collaborate with external vendors, including contract research organizations (CROs) and technology providers, to ensure seamless execution of data management activities. Provide oversight and guidance to vendors to ensure quality and timeliness of deliverables.

8. Cross-Functional Collaboration: Work closely with other departments, including clinical operations, biostatistics, and medical affairs, to support the overall clinical development strategy. Collaborate on protocol development, data analysis, and study reporting as needed.

Senior Data Team Lead - Requirements:

• Bachelor's degree in life sciences, computer science, or related field; advanced degree preferred

• Minimum of 7 years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry

• Proficiency with clinical data management systems (e.g., Oracle Clinical, Medidata Rave, IBM Clinical Development) and electronic data capture (EDC) platforms

• Strong understanding of clinical trial processes, including protocol development, study conduct, and regulatory requirements

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

• Demonstrated leadership abilities, with experience in mentoring and managing junior staff

• Detail-oriented with a focus on quality and accuracy in all data management activities

• Familiarity with industry standards and best practices in clinical data management (e.g., CDISC standards, SDTM/ADaM)

• Ability to thrive in a fast-paced environment and manage multiple priorities simultaneously

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.