Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Clinical Project Manager will plan, monitor and coordinate clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures and Corporate Policies, Guidelines and Standards.
Essential Responsibilities: Duties include (but are not limited to):
Participates in selection process of external Service Providers (SPs)
Builds a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks
Translates technical requirements from R&D project teams into scope of work for execution by SPs.
Builds strong relationships to maximize performance and value delivered by SPs
Creates a culture of joint accountability to ensure Vendor performance
Develops, maintains and shares Good Vendor Management Practices
Facilitates efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences.
Facilitates final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing
Facilitates vendor training on applicable GEHC SOPs
Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs.
Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits.
Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports
Collects and processes regulatory documents and correspondence.
Negotiates and tracks center/trial budget according to financial agreement with each centre
Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested
Ensures that clinical trial sites have adequate supplies to perform the trial
May supervise the work of more junior Clinical Research Associates
Quality Specific Goals:
Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements: Master’s degree in a science related field with a minimum of 5 years of experience with clinical trials management within the healthcare industry or a Bachelor’s degree in a science related field with a minimum of 7 years of experience with clinical trials management within the healthcare industry
Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results
Proven communication skills, both written and verbal, at all levels of an organization
Must be willing to travel as required
Excellent communication and interpersonal skills
Well organized and structured, attention to detail
Ability to work independently and systematically
Diplomatic, cooperative teamworker
Locations: United States; Massachusetts; Marlborough
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