Clinical Trial Manager
Ignite Human Capital
Remote
Job details
Estimated: $110,000 - $140,000 a year
Full time
Job description
Hello!

A great opportunity is looking for a qualified individual to fulfill a remote position with an amazing and growing pharma company located in San Diego! The job description goes as follows:

Overview:
Patients and their challenges provide tremendous drive and meaning to what we do at this company. We seek a talented and successful individual that deeply desires to participate in our process to make medicines that change a patient’s life forever.

Job Description:
The Clinical Trial Manager (CTM) in collaboration with the Associate Director, Clinical Operations (AD CO) or Clinic Project Manager (CPM), contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. The CTM is responsible for oversight of site activities as well as for all aspects of monitoring team performance such as patient recruitment, quality of the clinical data, completeness of the TMF and compliance with SOPs and GCP. This position maybe remote or a hybrid of remote/in office, depending on where the successful candidate is located.

Role Purpose:
  • Key support role to the CPM; accountable for oversight of site activities as well as monitoring team performance.
  • Oversees components of clinical trials and ensures that they are executed to specified quality standards, meets project timelines and within budget.
  • Provides GCP expertise and brings to bear best practices in areas of oversight, including: monitoring, TMF content, clinical trial supply, and sample collection
Primary Responsibilities:
  • Thoroughly understands clinical trial protocols and site specifications and manages the oversight of the data delivery process in clinical trials ensuring consistency with protocols, including participation in data review/reconciliation efforts.
  • Oversees monitor performance including development of the study monitoring plan and oversight of activities at the study level. Responsible for site monitoring report review as well as adherence to the study monitoring plan and applicable SOPs and processes. Proactively communicate issues to the CPM.
  • Responsible for managing the creation, maintenance and close out of Trial Master File (TMF) activities. Contributes to TMF quality plan development. Performs QC of Trial Master Files.
  • Responsible for oversight of site activities. Manages aspects of the relationship with trial sites; works with CPM or other Clinical Operations senior staff to resolve issues or problems with the sites
  • Ensures patient enrollment activities are within protocol guidelines.
  • Contribute to the development of and ensures adherence to the clinical trial study plans (quality, vendor management, data management, site monitoring, TMF quality control, and study communication plans)
  • Supports the CPM in the set-up, conduct, and close out of clinical study activities, including management of vendors.
  • Tracks the clinical trial budget by reviewing invoices and identifying changes in scope.
  • Provides study level information to enable accurate and efficient supply of clinical product to the sites. Proactively identifies and communicates potential risks/challenges.
  • Reviews and provides input to clinical protocols for feasibility of clinical trials delivery; looks for short and long-term potential obstacles or opportunities for accelerating delivery of a clinical study
  • Tracks elements of the clinical trial project timelines on a day to day basis, proactively alerting PM and/or senior Clinical Operations staff to risks / challenges
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs or delegate; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Interfaces with other functional groups to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process. Supports CPM in preparation of study reporting.
  • Supports CPM in ensuring that patient enrollment activities are conducted in a timely manner.
  • Provides study level information to ensure timely database lock can occur.
  • Actively participates in the development of department initiatives, may act as lead on the development/definition of certain SOPs and processes under the leadership of more senior Clinical Operations staff; provides suggestions on department initiatives and goals that will support and enhance the vision and mission of Clinical Operations
Qualifications:
  • Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g. Microsoft Project, Word, Excel, Power Point) and programs.
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Learns, interprets, and explains protocol requirements to others.
  • Manages components of clinical trials independently with limited general guidance from senior staff.
  • Strong communication, verbal, written and presentation skills.
  • Bachelor’s degree in relevant field or equivalent experience
  • 4+ years experience in Clinical Trial Operations or Research
  • Ability and willingness to travel as needed
  • Maximum flexibility to adapt to changing program needs in real time
  • Excellent oral, written, and communication skills required
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