About Alkeus Pharmaceuticals
Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010 since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.
Position Summary:
We seek an experienced clinical data manager to join our innovative team. The ideal candidate should have extensive knowledge of the clinical data management principles, regulatory guidelines and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.
Primary Responsibilities:
The primary responsibilities of the role will be leading the clinical data management department.
- Develop / maintain / oversee data management documentation, including study protocols, case report forms and data management plans.
- Design / oversee the development of case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
- Perform / 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 (SOPs) 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 successful mitigate risk and oversee work on an ongoing basis.
- Develop and execute data management timelines to deliver accurate and complete data on time.
Skills and Qualifications:
- 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 (EDC) systems and clinical data management software.
- Familiarity with relevant regulations and guidelines, like 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 (e.g., SDTM, ADaM).
- Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Understanding of data privacy and protection regulations (e.g., GDPR).
- Effective communication and interpersonal skills to collaborate with other teams.
Skills and Key Success Factors:
- Entrepreneurship spirit with a passion to build, learn and evolve with the team.
- Highly organized and detail oriented with a passion to deliver quality results.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values, and ethical standards
- Ability and aptitude to manage ambiguity and adaptability to change
- Emphasize the need for self-motivation and the ability to work independently