Senior Clinical Trial Manager (Contract)

Job Description:

POSITION SUMMARY

The Senior Clinical Trial Manager (Contract role) will be responsible for overseeing all operational phases of clinical research, from start-up to database lock, ensuring studies are completed on time, within budget and in compliance with ICH-GCP guidelines and regulations.

RESPONSIBILITIES

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

• 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, annual 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 
• Travel up to 25% of the time 
• Perform other TransMedics 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

• This is a standard office position

MINIMUM QUALIFICATIONS                                                         

• 8-10 years experience in medical device (strongly preferred), pharmaceutical drug development, biotech or CRO industries 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                                         
• 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 

PREFERRED QUALIFICATIONS

• Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience
• Proven expertise in executing IRB/EC submissions and approvals                                         

• 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 interfacing with multiple vendors/contractors 
• Proven ability to handle multiple projects and changing priorities 
• Must be results-driven and exhibit a sense of urgency 
• Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information 
• Strong initiative and positive attitude 
• Ability to support and build collaborative relationships both internally and externally 
• Demonstrated ability to make timely decisions using sound judgment 
• Experience with electronic data capture (EDC)