Senior Clinical Trial Manager

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

The Senior Clinical Trial Manager will support the team in the planning, implementation, and oversight of Bicycle’s clinical trials to ensure it is conducted in accordance with study plans. He/she will execute on decisions and strategies for achieving clinical program objectives, and partner with matrixed functions such as clinical sciences, translational sciences, medical, program management, and finance. He/she will also interact frequently with external parties, such as study sites, vendors, investigators, and advisors.

The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations

Key responsibilities:

Lead clinical study project activities include site activation, patient enrollment, investigator meetings, data management, and study drug supply, among others
Support and provide guidance to the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines
Lead the oversight of 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

Lead activities in:

Contracting and activation of study sites;
Preparation and submission of IRB/EC packages;
Planning and conduct of investigator meetings;
Coordination of study drug and study supplies;
Management of patient sample collection, archival, and distribution to vendors;
Collection or preparation of study-related documents;
May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance and monitoring oversight.

Qualifications

Essential: 

Bachelor’s degree in scientific, biological, life sciences, or related field;
Demonstrable experience with ICG, GCP, and FDA requirements, as applicable, for clinical trial management;
Strong project management and organization skills; demonstrated ability to complete a task from start to finish;
Experience managing clinical CROs and/or clinical vendors;
Experience managing a budget and providing frequent updates on spend vs. budget;
Strong organizational skills and enjoys working in a methodical way;
Strong analytical and problem-solving skills;
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment;
Attention to detail and quality;
Excellent written and oral communication skills;
Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint);
Flexible approach to change.