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Research Data Manager

5 months ago

Rockville, United States Sunstone Therapies Full time
Job DescriptionJob Description

Scope: The Research Data Manager will play a critical role in supporting the clinical research team by overseeing the collection, management, and analysis of research data generated from psychedelic-assisted therapy clinical trials. This individual will collaborate closely with clinical research coordinators, principal investigators, and external partners to ensure the integrity, accuracy, and compliance of research data throughout the research process.

Job activities include but are not limited to:

1. Data Management

  • Develop and implement data management plans and standard operating procedures (SOPs) for clinical trials, ensuring compliance with regulatory requirements and industry best practices.
  • Design and maintain electronic data capture systems and databases for the collection, storage, and retrieval of research data.
  • Perform data quality control checks to identify and resolve discrepancies, errors, or missing data in a timely manner.
  • Ensure the security, confidentiality, and integrity of research data through appropriate data encryption, access controls, and backup procedures.
  • Generate and distribute data reports, summaries, and visualizations to support research activities, regulatory submissions, and scientific publications.
2. Data Analysis
  • Interpret and communicate study findings to internal stakeholders and external collaborators through written reportsSupport the development of data analysis plans, and data monitoring committees (DMCs) for clinical trials.
  • Assists with creation of source documentation and extrapolates data from source records into case report forms for all patient visits, ensuring timely dated submission in accordance with Sunstone Therapies and Sponsor requirements.
  • Actively participates in sponsor monitoring and auditing visits, ensuring that all data and queries are resolved in accordance with Sunstone Therapies and sponsor requirements
  • ​​​​​​​Assist with scheduling follow up appointments and/or procedures required to maintain protocol compliance
  • Maintains health/research records according to the practice policies, sponsor confidentiality agreement, HIPAA guidance guidelines, and any other applicable regulations
  • Utilizes Sunstone Therapies’ clinical trial management system to access research forms and keep currentall applicable patient reporting and tracking functions.
3. Regulatory Compliance
  • Ensure compliance with applicable regulations, guidelines, and standards for data management and protection, including Good Clinical Data Management Practices (GCDMP) and International Conference on Harmonization (ICH) guidelines.
  • Assist with regulatory submissions, audits, and inspections by providing documentation and data as requested.
4. Team Collaboration
  • Collaborate closely with clinical research coordinators, principal investigators, and other members of the research team to coordinate data collection activities and ensure data accuracy and completeness.

The successful candidate must demonstrate the following skills, experience and competencies:

  • Bachelor's degree in a relevant field (e.g., computer science, statistics, public health)
  • Minimum of 3 years of experience in clinical research data management, preferably in a pharmaceutical, biotechnology, or academic research setting.
  • Proficiency in data management software and tools, such as electronic data capture (EDC) systems, relational databases, and statistical software (e.g., SAS, R, SPSS).
  • Strong understanding of clinical research methodology, regulatory requirements, and ethical principles governing human subjects research, particularly in the context of psychedelic-assisted therapy.
  • Excellent organizational, analytical, and problem-solving skills, with meticulous attention to detail.
  • Ability to work effectively in a multidisciplinary team environment and collaborate with stakeholders from diverse backgrounds.
  • Strong written and verbal communication skills, with the ability to convey technical information to non-technical audiences.
  • Flexibility to adapt to changing priorities and deadlines in a dynamic research environment.
  • Commitment to maintaining confidentiality and integrity in handling sensitive research data.

Compensation and Benefits

Sunstone Therapies offers a competitive salary package commensurate with skills and experience plus benefits that include medical, dental, and vision coverage, and a retirement savings 401(k) plan.