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Project Manager
Ref No.: 18-14027
Location: Gaithersburg, Maryland
Position Type:Prof (T)
Start Date / End Date: 10/29/2018 to 10/28/2019
Job Description:
  • Act as a lead for study internally
  • managing vendors
  • taking a study from start to finish
  • excellent communication and organizational skills
  • leadership skills
Position Summary:
  • Plan and manage overall clinical operations for assigned clinical trials)/projects including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. Provide matrix management of functional area representatives to cross-functional clinical trial teams (CTTs).
Major Duties and Responsibilities:
  • Convene and lead cross-functional clinical trial teams (one or more)
  • Define and manage accountabilities for all clinical trial team members
  • Collaborate with AD/D, Clinical Operations to ensure proper resourcing for assigned trials
  • Contribute to the Clinical Study Protocol (CSP) and may contribute to the Protocol Concept Sheet(PCS)
  • Develop outsourcing specifications for vendor requests for proposal and scope of work agreements
  • Participate in and guide study team in vendor selection
  • Manage the vendor(s) throughout the life of assigned clinical trial(s)
  • Select investigational sites with input from Clinical Development and vendors
  • Review, refine, and approve Clinical Operations Plans including study monitoring and other plans
  • Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) Team members including Clinical Research Associates (CRAs)
  • Lead ongoing review of data to ensure quality and consistency
  • Plan and conduct investigator meetings and can support advisory board planning and conduct ad boards
  • Develop and manage study budget and may develop and manage program budgets
  • Oversee site agreement/budget negotiation process
  • Develop and manage study timelines (including recruitment) and may develop and manage program timelines
  • Manage and lead CTT risk &opportunity management
  • Oversee the submission of trial-related and essential documents to the Trial Master File
  • Identify and provide solutions to clinical trial issues
  • Provide input into non-project related activities and development of procedures as requested
  • Mentor staff and serve as a resource for new employees
  • May serve as a line manager of Project Coordinators
  • Provide or facilitate training to clinical study teams on protocol specific topics
  • Participate as appropriate in internal and external audits
  • Other duties as assigned
  • University degree, preferably in a biologic/scientific discipline
  • Minimum of 5 years progressive experience in clinical operations including project coordination, site management and monitoring or equivalent and at least 3 years of project management experience or equivalent.
  • For Sr. CPM: a minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent.
Special Skills/Abilities:
  • Thorough understanding of country level regulations, ICH and GCP guidelines
  • Thorough understanding of cross-functional clinical processes including data management,
  • biostatistics, medical writing, drug safety, and regulatory affairs
  • Demonstrated ability to lead a cross-functional team in a matrix environment
  • Strong interpersonal and negotiation skills
  • Strong verbal and written communications and presentation skills
  • Proven problem solving and decision-making skills
  • Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills
  • Potential to line manage personnel
  • Ability and willingness to travel 25% of the time (internationally and domestically)
Job Complexity:
  • Provide technical solutions to a range of difficult problems
  • Ability to manage early stage clinical trials) and potentially large/global clinical trials with low to moderate complexity
  • Work under a moderate level of oversight of Sr CPM or AD/D Clinical Operations
  • Develops approach to solutions and seeks guidance as appropriate
  • Work is reviewed for soundness of technical judgement overall adequacy and accuracy
Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Asha Krishna
Email: | 732-395-4591