Full Job Description
Job purpose
The Clinical Trial Manager (CTM), is responsible for the management of all aspects of Clinical Trial activities for their assigned Trial(s). This includes the efficient execution of BED sponsored clinical trials in overall compliance with Good Clinical Practice (GCP), Country Regulations and company Standard Operating Procedures (SOP's), according to time and budget.
This position will operate on a hybrid work schedule, with the expectation of working onsite 3 days a week in our office located at 197 First Avenue, Needham, MA.
Main Responsibilities, Activities, Duties and Tasks:
• In accordance with BED SOPs: plan, implement, monitor and report on progress against project plans and revise/update as necessary throughout the lifetime of the study.
• Lead the combined study team ensuring effective cross-functional teamwork, while managing trial timelines, budgets, resources, vendors and strategy.
• Work directly with internal teams and external partners to create and proactively manage trial timelines, budgets, resources, vendors and strategy.
• Maintains tracking and provides reports on clinical trial progress against timelines and budget. Monitor trial assumptions, schedule and costs to ensure all remain on track with the executed contract(s).
• Act as the primary contact point with CROs, clinical sites and vendors for assigned trial(s).
• Understand the trial delivery strategy, costing assumptions and resulting budget for assigned trial(s) in order to manage vendors.
• Ensure that a robust risk mitigation strategy is in-place, regularly monitored for each study, and any issues are escalated as needed to appropriate stakeholders.
• Track and forecast changes in SOW and associated budget including forecasting annual and 5 years planning /spend.
• Other duties as determined by business needs
Education/Qualifications
• Must have a life science or nursing degree or a similar qualification.
Professional Experience, Knowledge, & Technical Skills:
• Must have at least 3 years of previous trial management experience at trial management level on international clinical trials in pharmaceutical and/or CRO industries.
• Oncology clinical trial experience desirable.
• Experience with Radiopharmaceutical clinical trial management highly desirable but not mandatory.
• Knowledge of ICH GCP, international regulatory requirements & guidelines for the conduct of clinical development programs is also a bonus.
• Excellent decision-making, facilitation, communication and organizational skills.
• Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Must be able to understand, interpret, and explain protocol requirements to others in a clear and concise manner.
• Must have prior monitoring experience as co-monitoring may be required.
• Experience and skilled with cross-functional and highly matrixed organizations.
• Demonstrated ability to handle multiple competing priorities, utilize resources effectively and adapt flexibly to changing priorities.
• Effective computer skills with good working knowledge of a range of computer programs.
• Team player.
The salary range for this position is $125,000 - $135,000.
