Clinical Data 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 Data Project Manager.  This position is a remote/home based role located anywhere in the USA or Canada.

POSITION DESCRIPTION

As a Clinical Data Project Manager, you will provide a customer focused leadership role in managing multiple Phase I through Phase IV clinical research trials across multiple functional areas including Data Management, Programming, and Biostatistics.  You will manage the project team in the delivery of quality clinical data management services to achieve successful overall project completion.  You will monitor adherence to project contract and budget and will assist with proposal generation within a multifunctional matrix setting.   You will also assist in business development activities to achieve high level of customer satisfaction and therefore ensuring repeat business opportunities.

DUTIES AND RESPONSIBILITIES

  • Plans, organizes, and manages all aspects of assigned projects together with the functional Team Leader(s)
  • Ensures that the needs and perspectives of other functional areas (Biostatistics, Clinical, Safety, and Medical writing) are taken into account and integrated effectively in planning and execution
  • Reports progress against schedules to management as appropriate
  • Manages overall project budget and payment status. Reviews and manages variances between actual and forecast spend across the operational budget
  • Informs management of any relevant specific issues or situations that may require their assistance or intervention.
  • Requests resources as needed by the project to the Data Management Director, Biostatistics director and Medical Writing director as appropriated.
  • Has to be aware of and work to the standards appropriate to the study (Linical or Sponsor)
  • Prepares data management bids and proposals
  • Attends bid defense and sponsor meetings
  • Reviews work produced by project teams and supports identification of out-of-scope project work and assesses the need for change orders. Assists project teams in problem resolution such as deviation from project plans
  • Oversees the project team to ensure timely delivery of high-quality deliverables
  • Functions as primary liaison between the customer and Linical.
  • Facilitates the resolution of any problems arising from the client relationships by confronting constructively issues such as initial contract negotiations, project staff performance, turnover on the project, outstanding invoice payments, change orders negotiation, etc.
  • Acts as a bridge between operations, business development and other global support groups and assures the integration of all functions to ensure client satisfaction
  • Approves and signs off on study-related invoices. Oversees the reconciliation of invoices against scope of work and completed activities

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 Data Management, and three to five (3-5) years’ Study Lead experience managing studies in a CRO environment.  One to two (1-2) years’ experience as a Clinical Data Project Manager experience is preferred.
  • 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 https://www.linicalamericas.com.

Linical 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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