Job Description
We are looking for a Clinical Trial Manager that will support the team in planning, implementation and oversight of Bicycle’s clinical trials. In this role, they will be responsible for communicating effectively with internal and external study personnel and in facilitating the activities associated with the successful clinical trial management and execution of Bicycle’s clinical programs.
The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations.
Lead the cross functional clinical study team(s) to ensure successful clinical trial implementation and protocol execution including planning, execution, and close-out
Manage and oversee activities at the CRO and other clinical vendors; monitor status and provide real-time updates to program team; facilitate communication between bicycle and the Clinical CRO
Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
Responsible for ongoing study communication and escalation of study-related issues as required
Contribute to the writing and development of clinical documents such as Protocols, Informed Consent Forms, Investigator Brochures, project plans, pharmacy manuals, study reports and annual reports
Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
Review of data management aspects of clinical trials
Support clinical operations functions during audits (e.g. BIMO, FDA)
Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTA
Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
Fully understand the need for and importance of being inspection ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps
Assist CRO with planning of Investigator Meetings and associated travel
Interface with other internal functions to coordinate relevant and timely exchange of information/materials to support clinical trials
Support invoice and budget activities for clinical trials
Facilitate review of clinical trial agreements such as contracts and licenses
Identifies potential risks from study and site perspective and works with the team to assist in proactively resolving issues with CROs
Participates in UAT for EDC/IRT
May perform periodic visits to sites and/or CRO to assess progress of studies/protocol compliance