Clinical Trial Manager
The O'Connor Group
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Tech Stack
About the role
- Provides operational support to the program lead to ensure project milestones delivery on time, within budget, with high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines and applicable SOPs.
- Manage essential clinical trial duties and responsibilities as independently as possible, with guidance and oversight provided by leadership when needed.
- Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking of performance metrics and quality indicators.
- Serves as an escalation point and resource for study team and investigational sites.
- Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders.
- Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc.
- Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate.
- Responsible for and participates in clinical vendor selection process as a part of outsourcing activities.
- Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations).
- Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
- Creates, manages, measures, and reports timelines for milestone deliverables.
- Oversees/facilitates site feasibility/selection processes.
- Develops/oversees subject recruitment/retention strategy and related initiatives.
- Oversees internal team meetings, investigator meetings, and other trial-specific meetings.
- Participates in the development, review, and implementation of departmental SOPs, initiatives and processes.
- Reviews/approves vendor invoices for all clinical trial vendors including investigative sites.
Requirements
- BA/BS
- 4+ years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). Preference to candidates with prior small company experience and 1+ years management experience.
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required.
- Vendor oversight including operations and budget
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
- Willingness to travel as needed, up to 30% including overnight and international travel
Benefits
- This job operates in a professional office environment.
- This role routinely uses standard office equipment such as computers, phones and photocopiers.
- This position is required to work occasional nights and weekends to meet company demands.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementdata managementrisk managementstudy planningperformance metrics trackingquality indicatorsvendor selectionstudy document developmentsubject recruitment strategybudget management
Soft Skills
independent judgmentproblem-solvingcommunicationleadershipteam managementstrategic inputproactive managementorganizational skillscollaborationmeeting facilitation