Principal Clinical Trial Manager

Job Description:

POSITION SUMMARY The Principal Clinical Trial Manager provide leadership in the development of clinical trial activities and ensure that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.

RESPONSIBILITIES This position is responsible for, but not limited to, the following:

Leading the process of pre and post market clinical trials for FDA by employing effective organizational strategies and reviewing and presenting the results using rigorous clinical procedures

Responsible for creating study specific templates across all programs

Responsible for managing the planning, implementation, and tracking of the clinical monitoring process with CRAsProvide oversight of drafting all annual and bi-annual pre and post market reports to FDA in collaboration with the regulatory team

Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)Own and manage all trial start-up, conduct, and close-out activities according to industry and corporate standards

Lend expertise to the preparation of key clinical documents in conjunction with other team members (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, etc.)Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track

Track internal metrics, timelines and budgets

Communicate trial status to trial team Prepare and present trial specific updates to management

Oversee and participate in monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and take ownership for data completion and accuracy

Interact with data management personnel to plan, monitor, and execute data analyses

Support applications and technical files as needed

Collaborate with project specific committees (e.g., DSMB, CEC)
Assist with preparation for investigators’ meetings

Work with vendors as needed

Perform other Trans Medics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES None (Standard office environment).Travel up to 25% of the time MINIMUM QUALIFICATION SBA/BS in Science, Life Sciences or relevant field8-10 years’ pharmaceutical drug development, biotech or CRO industries experience monitoring and managing clinical trials (cardiovascular therapeutic indications preferred); or equivalent combination of education and experience. Proven expertise in executing IRB/EC submissions and approvals PREFERRED QUALIFICATIONS Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience

Experience in medical device (strongly preferred),Outstanding track record leading large complex global clinical trials for medical device products in different phases of the product cycle

Broad and deep knowledge of device clinical trial documentation requirements including monitoring requirements, FDA regulations, and operational aspects of clinical trials

Experience complying with GCP, ICH, ISO and FDA regulatory requirements

Proven ability to identify operational issues and proactively recommend and implement strategies to resolve problems

In-depth knowledge of adverse event investigation, analysis, and reporting procedures and standards

Willing to be held accountable for deliverables

Must be highly organized and detail oriented

Experience…