Clinical Trial Manager
Trillium Therapeutics Inc. is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. We employ biologic and small molecule-based approaches that enhance the ability of the patient’s own immune system to detect and destroy cancer cells. Headquartered in Mississauga, Canada, Trillium offers a flexible, diverse and inclusive workplace and market leading employee benefits. This role is based in Trillium’s US Office in Cambridge, MA.
Reporting to the Senior Director of Clinical Operations, the Clinical Trial Manager (CTM) manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, resources and vendors. The CTM may oversee the Clinical Research Organization (CRO) selection process for outsourced activities and oversee the activities of other service providers (for example, Central Labs) including negotiation of Scope of Work (SOW), budgets, performance management and issue resolution. The CTM will manage the successful delivery of these activities through adherence to Trillium Therapeutics SOPs (and Work Instruction documents), ICH-GCP and CRO oversight SOPs.
Management of all aspects of assigned clinical trials, including:
- Assist in designing, planning and implementation of clinical trials
- Track and report financial management, oversight and accrual of site contracts, patient fees, vendor contracts and CRO contracts to Trillium Finance
- Provide study specific direction and mentoring to internal stakeholders as well as external stakeholders including Principal Investigators (PIs), study coordinators, CRO clinical teams, vendor teams and others as directed by Trillium Executive Management
- CTM will provide mentoring and training to COAs, and Sr. COAs
- CTM will ensure all activities managed in remit of clinical trials will be completed in accordance with Trillium SOPs/WI (if applicable), local regulatory guidance including ICH-GCP and CRO SOPs (as noted by Transfer of Obligations or Roles and Responsibilities contract schedule)
- Prepare, manage and circulate study specific metrics and updates required for Executive Management and Board of Directors’ (BOD) meetings
- Attendance, where possible, at major scientific conferences were Trillium studies are presented
- Manage review for Quality Assurance and completeness of Trial Master File (TMF)
- B.Sc. or equivalent, in a clinical or scientific discipline
- 5 to 7 years of relevant clinical trial experience in an academic study center, pharmaceutical, biotechnology or CRO organization
- Experience with oncology trials is required to enable the candidate to make immediate contributions
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Ability to work independently and excellent written communication, oral communication, and organizational skills are required.
- Ability to manage priorities
- Strong interest in clinical trials and initiative to learn
- Enjoys working in an entrepreneurial, fast paced and changing environment
- Demonstrated personal leadership and organizational skills, along with problem solving, conflict resolution, and team building skills
- Detail and process oriented, with excellent project management skills, including risk assessment and timeline & contingency planning
- Knowledge of International guidelines and Regulations (e.g. ICH-GCP)
- Proven excellence in cross-functional matrix and/or cross-cultural partnership setting
- Ability to travel within US and Canada or other countries (10-15%), valid passport required
- Key competencies: action oriented, problem solving (solution oriented), dealing with ambiguity, drive for results, interpersonal savvy, informing, process management, perseverance
How to Apply:
Please send your resume and cover letter to firstname.lastname@example.org with the title of the role in the subject line. Kindly note that phone calls and third parties are not accepted. Candidates must be authorized to work in the U.S.