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Job Title: Clinical Operations Manager
Reports to: Site Director
Position Type: Full Time
Position Description: The Clinical Operations Manager is responsible for directing the operational and logistical tasks of clinical research operations to ensure the efficient execution of trials within established budgets and timelines, and in compliance with ICH GCP guidelines, sponsor requirements and FDA regulations.
Skills/Competencies
Excellent Communication, analytical and organizational skills
Leadership skills
Ability to collaborate effectively
Staff Management Proficiency
Strategic thinking and tactical implementation
Finance and budgeting knowledge
Key Responsibilities:
Direct, coach and manage clinical research staff in the conduct of clinical trials to ensure high quality and timely completion of research projects.
Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
Provide daily management and oversight of clinic support staff and operations at facility sites.
Develop and manage study timelines (including recruitment).
Ensures compliance with site Policies and Procedures and all other applicable laws and regulations.
Assist in development, interpretation and implementation of new policies and procedures.
Maintains frequent and meaningful contact with sponsor and CROs to assess performance and provide guidance as needed.
Ensure superior customer service for study volunteers, sponsors and vendors.
Train all new clinical research site personnel (except Investigators).
Plan and manage the daily workload of clinical research operations.
Attend all Pre-Study Site Selection Visits and Site Initiation Visits.
Collaborate with the Principal Investigator to ensure all staff are trained appropriately on study delegated duties.
Provide back-up for all Site staff as needed.
Perform screening visits and other visits, as needed.
Ensure compliance with proper utilization of the CTMS.
Provide high-level oversight for all monitoring visits.
Oversee the scheduling of Investigators and per diem staff to ensure proper coverage for the Site
Oversee the laboratory to ensure Site SOPS are followed.
Ensure all medical supplies are inventoried and ordered.
Work with local vendors to ensure all applicable trial related activities are conducted properly.
Oversee the submission process for all Regulatory items/response to Sponsor queries/processing of AE/SAEs.
Ensure quality assurance processes are in place and are followed by staff
Conduct Interviews and Performance Evaluations for staff
Approve timecards and vacation requests from staff
Work Environment: Work is generally performed within an office environment, with standard office equipment available, or remotely, as needed
Required education and experience:
Bachelors degree preferred
A minimum of seven years experience as a clinical research coordinator
A minimum of two years supervisory experience
One Year prior experience as a Site or Operations Manager preferred
Previous experience negotiating vendor/site contracts and managing budgets.
Thorough understanding of FDA, ICH and GCP guidelines.
Experience with Phase II-IV clinical trials.
Ability to effectively interface with medical personnel at clinical site(s).
Ability to lead multi-disciplinary, cross-functional teams both internally and externally.
Must be bilingual.