Clinical Data Management Director

4 weeks ago


Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full time
About Alkeus Pharmaceuticals

We are a clinical-stage biotech company dedicated to developing innovative therapies for serious eye diseases with high unmet need. Our team is passionate about making a difference in the lives of patients, and we are seeking a highly skilled Clinical Data Manager to join our innovative team.

Job Summary

We are looking for an experienced Clinical Data Manager to lead our clinical data management department. The ideal candidate will have extensive knowledge of clinical data management principles, regulatory guidelines, and industry best practices. They will be responsible for developing and maintaining data management documentation, designing and overseeing the development of case report forms and electronic data capture systems, and ensuring compliance with guidelines and regulations.

Key Responsibilities
  • Develop and maintain data management documentation, including study protocols, case report forms, and data management plans.
  • Design and oversee the development of case report forms and electronic data capture systems for data collection.
  • Perform and oversee data cleaning activities, including discrepancy management and query resolution.
  • Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
  • Develop and execute standard operating procedures for approval, data entry screen design and testing, validation check testing and approval.
  • Collaborate with study team members to resolve data-related issues and discrepancies.
  • Generate and review data listings, summaries, and reports for clinical study reports.
  • Serve as a primary resource for issues about data management.
  • Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards, and other relevant regulations.
  • Contribute to the development and validation of data management software tools.
  • Lead internal teams and effectively manage vendors for outsourced work.
  • Identify qualified vendors to perform data management work, develop key performance indicators to successfully mitigate risk, and oversee work on an ongoing basis.
  • Develop and execute data management timelines to deliver accurate and complete data on time.
Requirements
  • Bachelor's degree in a scientific or healthcare-related field.
  • 8-10 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
  • Strong understanding of clinical trial processes, data management principles, and regulatory guidelines.
  • Proficiency in electronic data capture systems and clinical data management software.
  • Familiarity with relevant regulations and guidelines, such as GCP and CDISC standards.
  • Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL, Power Query.
  • Excellent attention to detail with problem-solving and analytical skills.
Preferred Skills
  • Knowledge of CRF design, MS Project, and analytical capabilities.
  • Knowledge of CDISC standards and data interchange formats, such as SDTM and ADaM.
  • Familiarity with clinical trial design and basic knowledge of regulatory guidelines, such as FDA/CFR and ICH/GCP.
  • Understanding of data privacy and protection regulations, such as GDPR.
  • Effective communication and interpersonal skills to collaborate with other teams.
What We Offer

We offer a dynamic and innovative work environment, opportunities for professional growth and development, and a competitive compensation package. If you are a motivated and experienced Clinical Data Manager looking for a new challenge, we encourage you to apply for this exciting opportunity.


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