Clinical Project Manager

Stuart, United States

Linical Americas

Posted on: October 7, 2020

Closing: November 19, 2020

Salary: Undisclosed

Position Type: Full Time

Job Description

Linical is an industry leading, midsized, global contract research organization (CRO) with a significant footprint across North America, Europe, and Asia-Pacific. Linical provides the full spectrum of drug development services from early stage to large-scale, multinational studies. Our areas of expertise include Phase I-IV oncology, vaccine, infectious disease, CNS, and general medicine. Linical is the ideal partner for drug developers looking to expand their program into new markets, combining strong business and operational perspective with clinical and medical expertise.

We have an exciting career opportunity in the position of Clinical Project Manager.  This position is a remote/home based role located anywhere in the USA or Canada.

POSITION DESCRIPTION

The Clinical Project Manager is responsible for the overall management and oversight of contracted clinical trials, including (but not limited to) development of project documentation, training project staff, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables.

DUTIES AND RESPONSIBILITIES

  • Manage projects in a timely manner and in compliance with corporate SOPs and relevant regulations; liaise with other department managers as necessary
  • Develop and maintain detailed project plans, and oversee the maintenance of the project Trial Master File
  • Manage projects in accordance with the contract, proactively recognizing any changes in scope and collaborating with senior management to ensure timely completion of change orders
  • Effectively manage project budgets to ensure financial targets are met through regular reviews of indirect costs and project resources and by collaborating with Finance to ensure accurate revenue recognition
  • Monitor metrics to ensure quality and performance standards are met by all assigned project staff
  • Act as primary point of contact for client interactions, establishing and maintaining a positive client relationship throughout project conduct to help secure repeat business
  • Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and / or contract CRAs
  • Effectively manage staff through information-sharing, regular performance feedback, and goal­
  • setting, ensuring individual and team achievements are appropriately recognized
  • Ensure all necessary training is developed, delivered, and documented for assigned project staff
  • Provide coaching/mentoring to assigned project staff (APMs, ClLs, CRAs, and CTAs) by demonstrating leadership competencies
  • Develop a succession plan, and in the event of a team change, ensure a thorough and effective handover, documenting such per SOP
  • Manage staff utilization by reviewing timesheet information at regular intervals
  • Proactively identify potential resource issues to senior management
  • Provide regular updates on project status to senior management, including client satisfaction and staff issues
  • Participate in staff recruitment activities
  • Participate in process improvement initiatives as requested
  • Other duties as assigned

 REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in a life science or industry-related field is preferred
  • Minimum of ten (10) years’ experience in Clinical Operations, and three to five (3-5) years’ Study Lead and/or Project Management experience managing studies in a CRO environment.
  • Excellent working knowledge of ICH, GCP, and FDA guidelines and regulations.

Our employees enjoy a full range of comprehensive benefits to include but are not limited to medical, dental and vision insurance, company paid life insurance, paid holidays, PTO, 401K with employer match, long and short-term disability, and long term career growth and development opportunities. If you have the experience required and are looking to join an energetic and collaborative team, please apply directly to our website at www.linicalamericas.com.

Linical Americas is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Linical Americas

Posted on: October 7, 2020

Closing: November 19, 2020

Salary($): Undisclosed

Position Type: Full Time

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