Clinical Trial Manager

We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.

Prior to joining, your experience will have been from a clinical research organization, hospital or large medical specialty clinic, or work at another biopharma. You will be familiar with clinical data and clinical trial terminology, be able to read standard medical abbreviations that are used in the world of medical practice and clinical studies. You will have familiarity with FDA regulations, GCP, essential study documents, and key study activities such as tracking patient screening and enrollment, clinical laboratory sample collection, regulatory documents, and study team communications. Problem solving skills will be used daily. And did we mention - being highly organized is essential.

Essential Duties and Responsibilities:

Managing the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work

Leading both an internal and external/CRO study management team to ensure the successful conduct of clinical trials in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs

Authoring and reviewing as needed clinical study documents (Informed Consent Forms, Clinical Study Plans, Case Report Forms, etc.). Reviewing and contributing as needed to Investigator’s Brochure and other supportive regulatory documents

Driving IRB/ethics committee and regulatory submissions as needed to support study timelines

Effectively evaluating qualified study sites, performing site initiation, planning and presenting at investigator meetings/advisory boards, and implementing study start up activities, including development of documents related to conduct of the study (e.g., investigator binder, pharmacy binder, regulatory binder development, etc.) in collaboration with the clinical study team

Managing and reviewing study budgets and investigator grants

Overseeing interim study conduct, including management of operations/medical questions from CRO and sites, planning and facilitation of interim safety meetings, tracking subject recruitment, laboratory samples, and review of monitoring reports, and ensuring proper documentation is filed to meet GCP requirements

Assessing study drug requirements and shipment logistics; contribute to labeling strategy

Responsible for study close-out (CRO, third party vendors and internal close-out activities, invoice reconciliation for project closure) and ensuring study timelines are met

Reviewing, and contributing as needed, to support completion of the Clinical Study Reports

Overseeing TMF archival, submission and QC activities

Working efficiently, both independently and within a team

Training/mentoring junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned

Creation, training, review and approval of clinical operations program specific documents

May assist with the development of any new or updated SOPs/Work practices for the department

Trains and mentor junior staff or peer mentorship of new hires

Manages junior staff

Desired Skills & Experience:

Bachelor’s Degree required, relevant scientific or health-care related discipline highly preferred

Minimum of 4-6 years of clinical trial management experience, including protocol development, selection and management of CROs and contract vendors, timeline management, and budget management. Prior experience working in the biopharmaceutical industry is desired

Thorough understanding and ability to lead a cross-functional team through all activities in the full clinical study life cycle

Demonstrated proficiency in management of multi-center international clinical trials (from initiation to closure)

Experience managing outsourced work

Excellent interpersonal, communication (written and verbal), time management, presentation and organizational skills

Management or mentorship experience desired

Ability and willingness to travel 5-10% of the time (international and domestic)