Clinical Trial Manager / Senior Clinical Trial Manager

Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement

Working knowledge of clinical management techniques and tools

Direct work experience in a cross-functional environment

Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics

Proven experience in planning, risk management and change management

High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective

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 and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings