Reports To: Head of Clinical Operations
FLSA Status: Exempt
Responsible for timely execution of clinical studies such as site feasibility, pre-qualification, site initiation, routine monitoring and study close out activities. Ensures compliance with SOPs and Good Clinical Practice. Oversees and manages CROs, study contractors and vendors. Coordinates the training of Junior staff involved in clinical trial management. Responsible for management of timelines and budgets and collection of study metrics. Coordinates the training of staff involved in clinical trial management.
Key Accountabilities/Core Job Responsibilities:
- Assist in the preparation and finalization of project and study-related documents including: informed consent forms, pharmacy/lab manual, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
- Participate in the selection of clinical investigators and clinical study sites.
- Responsible for responding to clinical study site and study related issues and recommending corrective actions and/or escalating to supervisor.
- Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and study logs/forms including participating in the EDC and IVRS specification process and user acceptance testing.
- Ensure that CRF data queries are resolved appropriately.
- Coordinate and manage Investigational Product including shipment logistics, overall accountability and reconciliation.
- Coordinates the preparation of clinical site budgets.
- Manage project timelines and vendor performance to meet departmental and corporate goals.
- Manage payment process (i.e., study site invoices, field monitor invoices, etc.) for all clinical trial study sites and field monitors, and/or vendors.
- Monitor and track clinical trial progress and provide status update reports and study metrics.
- Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, imaging, central ECG, etc.).
- Responsible for selection of CRO study staff and coordinating training including documentation.
- Manages the training and oversees study contract field monitors (e.g., review of all trip reports) and provide guidance on clinical study site issues.
- Lead with minimal supervision in the planning of investigator meetings and making presentations, as required.
- Lead with minimal supervision in the review of clinical data at the CRF, data listing, and report table levels.
- Work independently in a fast-paced environment.
- Attend and/or participate in Site Initiation Visits (SIVs) and or Investigator Meetings as required.
- Co-Monitoring with field monitor(s) for adherence to protocol and GCP as required.
- Ensure all trip reports are reviewed and all action items are followed up per SOPs and work instructions.
- Identify and escalate site, vendor and study related issues to supervisor, as appropriate.
- Assist with Department compliance initiatives and SOP writing when opportunity arises.
- Ability to exercise independent judgment.
- Good organization and planning skills.
- Strong interpersonal skills and communication skills (both written and oral).
- Ability to problem-solve and multi task.
- Excellent comprehension of Good Clinical Practices and basic concepts of clinical research.
- Must be willing to travel at least 25%-35% of the time, as measured on a calendar quarter. Both domestic and international travel may be required.
- This position requires a minimum of 6 years of experience in the pharmaceutical/clinical research environment with at least 2 years of study management experience. People Management is a plus.
Where applicable if managing direct reports:
- Directly manages assigned staff member recruitment and on-boarding
- Oversees the work of direct reports to ensure on-time, on-target and within-budget results
- Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
- Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
- Provides formal performance reviews and career development planning for all direct reports
- Complies with all company policies and procedures, as well as state/federal employment- related laws
Education Requirements (degree, certifications, etc.):
- BA/BS/MS in scientific discipline or equivalent combination of education and related-work experience.
- Experience with development of prospective site-selection criteria.
- Protocol development experience.
- Familiar with advanced concepts of clinical research.
- Ability to deal with time demands, incomplete information or unexpected events.
- Experience in interactions with outside vendors, e.g., CROs and contract labs.
- Experience with administration of site budgets.
- Demonstrated ability to write and present clearly using scientific and clinical terminology.
The department head or designee will determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to internal training procedure.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability
I fully understand this position description and what is expected of me in this role. I have been given the opportunity to ask questions, and they have been answered to my satisfaction.