Senior Clinical Trial Manager

  • Location:Cambridge,MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Experienced

RESPONSIBILITIES:

  • Serve as primary operational contact and lead cross-functional teams in the execution of early phase clinical trials in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/Work Instructions
  • Ensure successful planning, execution, tracking, and delivery of quality clinical trials/deliverables within specified timeline and budget
  • Lead or participate in the selection, start-up, and management/oversight of clinical service providers/vendors (CRO, RTSM/IXRS, labs, etc.)
  • Develop/maintain effective investigator and internal and external collaborator relationships
  • Lead/assist in development of study oversight plans, quality plans, clinical components of regulatory submissions, risk management and corrective action plans, and study documents such as protocol, Investigator Brochure, informed consent forms, study execution plans, CRFs, Clinical Study Reports, etc.
  • Develop innovative country, site activation, and subject recruitment/retention strategies and related initiatives
  • Coordinate and/or oversee the study training for study teams, investigational sites, and vendors in collaboration with CRO
  • Monitor/oversee data quality and CRA, site, CRO/vendor performance/metrics and effectiveness of mitigative/corrective measures
  • Proactively manage issues and information sharing with key internal and external stakeholders with use of standardized reports and other mechanisms
  • Oversee creation, maintenance, and transfer of the electronic Trial Master File (eTMF)
  • Participate and respond to Quality Assurance and/or regulatory authority inspections and audits of sites and vendors
  • Oversee scopes of work, invoice reconciliation, and change orders and participate in reconciliation of monthly actual and forecast budgets
  • Evaluate and support the development and application of standardized operational processes and continuous process improvement initiatives, recommending/taking the lead for more efficient and/or effective approaches to clinical trials
  • Provide study-specific mentoring and line management for junior team members, as appropriate, as the needs of Clinical Operations grow

 

EDUCATION AND EXPERIENCE: 

  • Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
  • Minimum 8 years of progressively increasing clinical trial management experience within pharma, biotech and/or CRO
  • Extensive experience and expertise in managing complex clinical studies; Phase 1 oncology experience required
  • Knowledge of and ability to apply current FDA and global regulations and compliance guidelines to clinical trials using “best” industry practices and exercising highest ethical standards
  • Proactive and independent management and oversight of CROs, vendors, and consultants
  • Demonstrated skill in leading and collaborating with cross-functional teams and an ability to influence and provide direction and guidance to colleagues and partners
  • Critical, strategic thinker who uses sound judgment with respect to operational strategies and confidential information
  • Complex problem-solving skills and a broad perspective to deal effectively with ambiguity
  • Independent, able to adapt in a changing and fast-paced environment, not afraid to make decisions
  • Proficient in study monitoring activities
  • Strong understanding of cost drivers with the ability to proactively develop and manage/oversee study budgets
  • Strong verbal, written, presentation and computer skills, including knowledge of Microsoft Excel, Word, PowerPoint, Outlook and Project/equivalent
  • Flexibility to travel as needed (10-15%)