(PM - CTM) Project or Clinical Trial Manager - PERM placement in Burlington, MA

Kelly Clinical Resources is seeking a Project/Clinical Trial Manager. This is a permanent role.

Client: A full service CRO that focuses on Phase II through Phase IV product development in North American and Europe. They work with both all reputable pharmaceutical companies.

RESPONSIBILITIES:
The Project/Clinical Trial Manager will provide management support and coordinate project team activities. Candidate must be able to plan, execute, and close out project activities.

SPECIFIC DUTIES:
 Managing overall conduct of project to ensure the achievement of critical milestones in terms of time, cost, quality, and customer relationship.
 Act as a liaison with customers from both pharmaceutical and biotechnology companies as primary contact for project-related subjects.
 Responsible to write the project plan, including the communication plan and the quality management plan for the project.
 Responsible to conduct the hand-over meeting with Business Development for each of their projects.
 Responsible to organize and manage the kick-off meeting with the customer.
 Responsible to prepare monthly Management Reports that are presented to the customer either in person or, if the customer is not local, via teleconference.
 Responsible to manage resourcing throughout the life cycle of the project.
 Responsible to coordinate vendor activities related to the project.
 Responsible to organize and manage investigator meetings for the customer and actively participate if requested by customer.

REQUIREMENTS:
 Minimum of 3 years trial management experience in a CRO, biotech and/or pharmaceutical, industry with at least 1 of those years as a Clinical Research Associate and 2 years in Project Management.
 Demonstrated ability to manage complex trials.
 Proficient management experience in: time management (of self and others); communication; problem-solving, judgment and decision-making skills; service management.
 In-depth knowledge of ICH/GCP Guidelines, FDA Regulations and international guidelines governing the conduct of domestic and international clinical research studies.
 Proven people management experience including teambuilding and leadership skills.
 Excellent oral and written communication, problem solving, interpersonal, analytical and organizational skills.
 Computer literacy in MS Word, Excel and Power Point.
 Confident, motivated and dynamic team player, who can work effectively with minimal supervision.
 Bachelor of Science/Nursing degree or related health education.
 Bilingualism is an asset (French and English).

QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!

Kelly Scientific Resources(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research. Come join a winning team!!Kelly Services is an Equal Opportunity EmployerContact?Information?:.1 New England Executive Park
Burlington?MA?01803