ESSENTIAL JOB FUNCTIONS:

General:

• Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
• Collaborate with internal and external team members for the planning and execution of clinical trials.
• Accountable for coordination of planning, initiation, completion, and reporting of clinical study protocols within or across programs from team endorsement to reporting.
• Ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan.
• Lead the development of and provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc. Also performs review and provides strong operational input in the development of clinical trial protocols and CSRs
• Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).
• Collaborate with Legal & Clinical Contracting & Outsourcing (and others, as needed) on the development and management of study specific agreements/budgets (i.e., non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.).
• Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly.
• Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the business financial standards.
• Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
• Monitor and visit clinical study sites as needed.
• Track, collect, and review clinical documentation for clinical trials.
• Complete other duties as assigned by the manager.
• Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Strategy Team (CST).
• Serves as the key CST point of contact for the trial.
• Accountable for the successful preparation and presentation of operational content at key leadership discussions (CST, GPT, SLT, etc.).
• Ensures strong oversight, review, and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
• Accountable for partnering with CRO in audit responses and addressing quality issues.
• Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
• Ensures inspection readiness application for all assigned clinical trials.

Sr. CTL:

• Manages projects/work streams with high complexity, risk, impact, and reach. Manages large-sized global clinical teams with members also from outside the direct working environment.
• Coordinates stakeholders from closely related areas and beyond.
• Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people; creates and leads a positive working climate.
• Develop and lead operational and therapeutic area training for internal and external study team members.
• Directs multiple studies in parallel and/or be called upon for program management duties.
• Exhibits Subject Matter Expert level understanding of multiple functions and functional processes.
• Accountable for successful project execution including definition of milestones and clarification of project scope.
• Receives minimal guidance and works independently.
• Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projects

JOB SPECIFICATIONS:

• Advanced degree desirable; PM certification desirable
• Ideally 10 years clinical research experience with at least 5 years of direct trial management experience
• Some experience in oncology preferred.
• Experience in CRO oversight is required
• Manages large sized global clinical trial team
• Works with minimal or no supervision
• Ability to mentor junior staff
• Self-directed and proactive handles multiple complex tasks
• Strong organization, documentation, and communication skills.
• Excellent interpersonal skills: ability to collaborate across disciplines.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
• Ability to travel up to approximately 30% of time.
• Hybrid on-site in Boston two days per week.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.