Manager, Clinical Data Coordination

Raleigh, North Carolina (Remote)

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Posted 2 days ago

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry, one patient, at a time. To help us achieve our goal, we are seeking a razor-sharp Manager, Clinical Data Coordination eager to make an impact within a mission-driven organization.

The Manager of Clinical Data Coordination is responsible for a team of individuals that work in conjunction with the Clinical Data Management team to support the Clinical Data Managers for studies using Science 37’s proprietary electronic platform.  The Clinical Data Coordination team is responsible for building required eConsent forms and workflows in the Science 37 platform. In addition, the team supports the resolution of queries and other tasks as needed to support data cleaning and reconciliation.   

Duties include but are not limited to:

  1. Lead, direct, manage, develop, coach and evaluate direct reports, and other employees in group in accordance with the Company's policies and plans.
  2. Lead the Clinical Data Coordination team in building and validating the required eConsent forms and workflows in the Science 37 Platform based information within a study protocol
  3. Provide Support for the Data Management Team in the design and build of electronic case report forms (eCRFs) in the Science 37 Platform
  4. Interact with sponsors and auditors, as required, on Science 37 processes for eConsent build and query resolution.
  5. Create and execute plans for internal data review, quality checks and cleaning of data based on programmed edit checks and assist Clinical Data Manager in reviewing data on a regular basis looking for inconsistencies across patients and forms and issue queries appropriately
  6. Support in the training the different users in the trial team on use of the Science 37 Platform based on their role(s) within the study
  7. Define and Provide support to the Clinical Data Managers where needed during study start-up, study execution and study close-out based on resource capacity and experience of staff
  8. Escalate issues when appropriate to Product manager/Product Expert/Clinical Data Management Team
  9. Maintain, update and create SOP’s as needed for Clinical Data Coordination team.
  10. Work with Vice President of Data Management on resourcing model, pricing and outsourcing models to support the growth of Science 37.

Qualifications

  1. Bachelor of Science degree or equivalent experience in the health science field.
  2. Requires at least 5 years of experience in clinical research plus 2 years management experience.
  3. Experience in a fast-moving, growth-minded startup, and are comfortable with needing to be flexible and adaptable as requirements change.

Skills/Competencies

  1. Knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the success of a project.
  2. Strong communication and presentation skills- Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive project team member and internal Science37 relationships. Ability to conduct effective presentations. Ability to articulate ideas to both technical and non-technical audiences
  3. Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
  4. Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
  5. Organization and Analytical skillset – Demonstrate high level of attention to detail, outstanding organizational activities and good blend of analytical skills, strategic thinking, planning and implementation
  6. Time Management and Goal-Oriented – Have excellent time management skills, action-oriented, goal-oriented and innovative
  7. Other – Ability to communicate in English (both verbal and written)

Supervision

The position reports to the Vice President of Data Management who will also assign projects, provide general direction and guidance.

Direct Reports

  • Clinical Data Coordinators
  • Senior Clinical Data Coordinators

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!

Job tags: Computer skills MS Office Reconciliation Research Strategic thinking Training
Job region(s): North America
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