Manager/Senior Manager, Clinical Operations

Position Summary:

The Clinical Trial Manager/Senior Clinical Trials Manager will be responsible for the operational management and oversight of clinical trials within a clinical development program. The position will work closely with the Medical Monitor and other cross-functional representatives including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology and Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The position will also provide oversight of the CRO and other third-party vendors on the assigned study. This individual will report into the Head of Clinical Operations.

Key Responsibilities:

  • Responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies. 
  • Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision. 
  • Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.   
  • Actively provides operational direction and/or general supervision to direct reports
  • Assist with training and mentoring of internal clinical operations staff. 
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines. 
  • Manage CROs, vendors and consultants that are involved with the clinical trial and program. 
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits
  • Perform clinical data review of data listings and summary tables, including query generation  
  • Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
  • Develop and maintain good working relationships with investigators and study staff
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
  • Investigate queries, monitor discrepancies
  • Manage investigational product (IP) accountability and reconciliation process
  • Responsible for review or approval of IP release packages
  • Negotiate and manage the budget and payments for investigative sites
  • Develop CRA and third-party vendor training on protocols and practices 
  • Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned. 
  • Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work

Preferred Education/Experience:

  • Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is desired.

Knowledge, Skills and Abilities:

  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies
  • Ability to organize and manage multiple priorities required
  • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Proactive and positive management approach
  • Maximum flexibility to adapt to changing program needs in real time
  • Strong leadership skills and self-awareness
  • Ability to build strong relationships with co-workers of various backgrounds and expertise

We invite qualified candidates to submit their CV to: recruiting@appliedmt.com (note: ‘Please put job title in subject heading)