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Senior Manager, Data Management in Pharmaceuticals

On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

To thrive in this role, candidates should possess a Bachelor’s degree in Life Sciences or Mathematics (or a related field), with an equivalent combination of education and relevant experience considered. A minimum of 5 years of progressively responsible experience in clinical data management within the pharmaceutical, biotechnology, or CRO sectors, including at least 2 years in a leadership capacity, is essential. Essential Skills:Proven experience in managing and supervising Data Management teams. Strong knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHO Drug). Exceptional verbal and written communication, interpersonal, and organizational skills. Proficiency in MS Office applications and data management systems, with a solid understanding of statistical programs (e.g., SAS). Familiarity with database design and concepts. Demonstrated ability to ensure high-quality data management processes.

About the job

Join our dynamic team at California Creative Solutions Inc. as a Senior Manager of Data Management in the Pharmaceuticals sector. This full-time role is based in beautiful San Diego and is pivotal in ensuring the integrity and quality of clinical data management for our innovative projects.

As a Senior Manager, you will lead the Data Management team, overseeing the design, testing, and implementation of clinical data collection studies. Your expertise will be crucial in managing high-quality data deliverables for regulatory submissions, publications, and due diligence activities in collaboration with Contract Research Organizations (CROs).

Key Responsibilities:

  • Collaborate in designing and implementing clinical protocols and data collection systems.
  • Develop and uphold data quality plans.
  • Ensure timely execution of data management timelines for assigned projects.
  • Provide strategic input into protocol designs with a focus on data management.
  • Assist Biostatistics in the evaluation of Statistical Analysis Plans.
  • Identify and resolve data discrepancies using standardized validation systems.
  • Oversee the generation of quality data deliverables for regulatory, publication, and due diligence purposes.
  • Participate in reviewing clinical and regulatory documents to maintain data integrity and quality.
  • Manage projects in collaboration with CROs and lead internal project initiatives.
  • Contribute to the development of standards and process documentation, including SOPs and Work Instructions.
  • Support compliance with industry quality standards and guidelines.
  • Assist in selecting, developing, and evaluating personnel to ensure efficient operations.
  • Engage in the corporate and departmental budget processes and management.
  • Facilitate career development for Data Management personnel.
  • Perform additional duties as required.

About California Creative Solutions Inc.

California Creative Solutions Inc. is at the forefront of innovation in the pharmaceutical industry, dedicated to enhancing clinical research through precise data management and quality assurance. Our team is composed of skilled professionals committed to excellence and integrity in every project we undertake.

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