Job Description
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements. Primary clinical point of contact with the client. Collaborate with PM on monthly invoicing and variance management of clinical budget. Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials). Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment.
Develop and finalize country recruitment/retention strategy. Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits. Manage processes for investigational product (IP) including drug accountability and reconciliation. When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed.
About Precision Medicine Group
Precision Medicine Group is an Equal Opportunity Employer that makes employment decisions without regard to race, color, age, religion, sex, sexual orientation, etc.