Manager/Sr. 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
  • 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)

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets