Coordinate the activities associated with the evaluation, initiation and management of clinical trials.
Coordinate clinical and regulatory activities with company ex-US offices.
Lead in the selection and implementation of clinical sites.
Contribute to the preparation of clinical protocols and amendments.
Support the preparation and submission of regulatory reports and clinical study reports.
Provide technical, scientific, and administrative assistance to the department.
Manage vendors and communicate with sites and others within the company, both in, and outside the department.
Coordinate the organization of investigator meetings.
Assist in the design and format of CRFs, study guides and subjects leaflet.
Track CRO and third party vendor activities.
Identify, select, and implement clinical sites.
Coordinate the activities associated with start up and management of clinical sites.
Ensure budgets, schedules, and performance requirements are met.
Monitor progress of studies identifying delays and initiation of corrective actions when necessary.
Perform other duties as required.
Operate to the highest ethical and moral standards.
Comply with our policies and procedures.
Adhere to quality standards set by regulations, and company policies, procedures and mission.
Communicate effectively with supervisors, colleagues and subordinates. Be committed to team effort and be willing to assist in unrelated job areas when called upon.
Provide administrative leadership for company and provide knowledge-based expertise in related areas that can be applied to meeting the strategic goals.
Travel as needed.
Education Requirements / Experience Level:
RN/BSN or Bachelor's degree in a clinical or health-related field or in life sciences.
Master's degree in a clinical or health-related field or in life science is preferred.
Seven years of experience in monitoring, clinical trials management, and performing data management activities (e.g., data resolution, database lock, etc.) with a CRO, Pharmaceutical or Biotech Company
At least 8 years of in-house experience with a CRO, Pharmaceutical or Biotech Company and previous lead/clinical trial manager experience.
Ophthalmology experience is highly preferred.
Must be able to work office-based in San Diego, CA.
DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.
We offer competitive hourly rate, comprehensive benefits including paid days off, 401K, and health insurance.
Docs Global - 19 months ago