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Senior Clinical Trials Project Manager

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Location
Elmsford, NY
Salary
$130,000 - $150,000
Job Type
Direct Hire
Degree
Bachelor of Science, Bachelor of Arts
Date
May 23, 2017
Job ID
2479082
Senior Clinical Trials Project Manager
Elmsford, NY or Glasgow, DE (Relocation Provided)
Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits
 
We have a new opening for a Senior Clinical Project Manager with a longstanding client; a multi-billion ($8B+) global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's lives. A lot of the work they are currently doing is completely next-generation new product development, very exciting cutting edge products. The instruments are large and complex in nature.
 
The Senior Clinical Project Manager will focus on both product and chemical aspects of the instrument. The role will be responsible for project coordination of clinical trials being done in-house, investigational sites, and through CRO. They will manage 6-7 direct reports (4 are contractors). The key to this role is someone who is very strong in managing complex projects and people. The Project Manager will also be an individual contributor, but supervising others work. Key elements of project leadership for this role are protocols, reports, site selection, monitoring (when required - or delegated to a reporting CRA), and other responsibilities.
 
Details:
  • Provides study management and assures successful completion of clinical studies conducted worldwide consistent with applicable regulations, guidelines and policies.
  • Develops clinical strategy for products in development to achieve clearances and approvals and provides support and regulatory guidance.
  • Oversees and manages clinical project personnel and/or consultants.
  • Responsible for the day to day management of clinical trials (both independently and others work)
  • Manages activities performed by direct reports, consultants and/or Contract Research Organizations.
  • Leads in the development of clinical strategies for products in development.
  • Participates on product development teams as clinical representative.
  • Ensures appropriate resources and priorities are maintained for the assigned projects.
  • Monitors or ensures adequate oversight of study is conducted.
  • Creates, improves and implements departmental procedures and clinical trial documents.
  • Communicates and presents study results and program issues to project team and other key internal stakeholders (development, marketing, operations, etc.).
  • Manages clinical development budget within stated financial goals.
  • Monitors compliance with all FDA and applicable regulations concerning clinical activities.
  • Oversees the internal and external audit programs for clinical studies.
  • Evaluates clinical data/information and writes reports, abstracts and papers as required.
 Desired Qualifications:
  • Bachelor of Science in scientific discipline (or equivalent experience), Masters desired but not required
  • Minimum 5+ years demonstrated experience managing clinical activities in a medical device or in vitro diagnostic field.
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Demonstrated experience in managing clinical trials, including risk assessment and contingency planning.
  • Monitoring experience required.
  • Data management experience desirable.
  • Excellent communication, project and people management, organizational, problem solving, conflict resolution, leadership and team building skills.