Sr. Clinical Trial Leader
Proclinical is currently recruiting for a Senior Clinical Trial Leader with our client located in Irvine, CA. Successful candidate will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
- Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines.
- Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
- Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- May serve as the primary contact for clinical trial sites (e.g. site management).
- Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision.
- Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on clinicaltrials.gov).
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Oversee the development and execution of Investigator agreements and trial payments.
- Responsible for clinical data review to prepare data for statistical analyses and publications.
- If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
- Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Track and manage assigned project budgets to ensure adherence to business plans.
- Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
- Develop a strong understanding of the pipeline, product portfolio and business needs.
- May serve as the clinical representative on a New Product Development team.
- May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports.
Skills and Requirements:
- BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
- Previous experience in clinical research or equivalent is required.
- Experience working well with cross-functional teams is required.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
- Clinical/medical background a plus.
- Experience managing projects a plus.
- Medical device experience highly preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.