We are seeking a well experienced Clinical Operations Consultant to manage clinical trial operations from study start-up through database lock. The Clinical Operations Consultant will ensure GCPs and relevant SOPs are met, manage and act as primary point of contact for CRO’s and contract labs.
- Actively partner on CRO selection activities and RFP process; identify the scope of work, study needs, CRO selection, vendor management plan, reviews quality metrics.
- Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning.
- Tracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance.
- Performs and/or oversees site monitoring visits for clinical trials as needed including and not limited to ensuring clinical supplies accountability records are maintained.
- Provide operational review and content to the study protocol and coordinate completion of protocol QC review.
- Conducts thorough review of key specification documents related to the trial and oversees/participates in the UAT for IWR, EDC, eDiary and other systems.
- Provide content for study related systems and portals.
- Provide input/develop study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and approval for site receipt of study drug.
- Serve as the clinical operations representative in meetings and provides necessary input into key process related documents.
- Lead meetings
- Manage and execute vendor kick off meetings, face-to-face meetings, team training, and WebEx trials as required.
- Coordinate and lead investigator meetings including development of the agenda, meeting planner activities, development and delivery of presentation
- Lead clinical operational team meetings: draft agenda, collect minutes, file minutes in the TMF, track action items, provide ongoing status of trial enrollment and timelines, outline vendor related deliverables, communicate risk/issues, and manage input from other internal and external partners.
- Provide administrative oversight
- Oversee the development, review and operational aspects of site investigator grant and grant payment.
- Track and obtain necessary approvals related to vendor contract change orders. Approve study invoices related to trial vendors.
- Perform/coordinate monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered.
- Provides oversight to staff maintaining clinical trial master files to ensure compliance.
- Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring.
- Support QA and regulatory agency activities related to trial clinical execution audits (e.g. sites, TMF, etc.) coordinate responses/corrective actions related to a
Experience & Skills Required
- MUST BE ABLE TO WORK ON SITE
- 5 years of clinical study management experience with a minimum of 2 years of leadership/project management preferable over global clinical trials.
- Experience in management of contracted resources/CROs, site monitoring and clinical quality compliance.
- Strong CRO oversight and operational management skills with proven attention to detail.
- Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is preferred.
- Effective oral/written communication and interpersonal skills.
- Advanced computer skills including proficiency in MS Office.
- Willingness to travel up to 20% including domestic and international travel.