Project Manager - Early Phase Trials

Location: United States

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Requisition Number: 4992

Position Title: Project Manager EP

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.  

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 

What you will do

The Project Manager (PM) will manage multiple Phase I through II clinical trials that may be local, regional or global in scope. Worldwide Clinical Trials Project Managers are 100% accountable for the success of their projects: Project Manager (PM) is responsible for the overall coordination and management of clinical trials from start  up through the final project deliverable.
Directs the technical, financial and operational aspects of the projects
Works with functional area leads to identify and evaluate fundamental project requirements, interpret data on complex issues, is responsible for contingency planning and implementation of rescue strategy where needed  and ensure solutions are implemented.
Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations
The PM, with support from the Director, Project Management, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations.
 

  • Serve as the primary point of contact for sponsor companies throughout the project lifecycle
  • Proactively manage operational aspects of project team including management of trial timelines, budgets, resources, and vendors
  • Leads the study start-up process including the conduct of the trial kick-off meeting, oversight of site(s) startup, set-up of the trial master file (TMF), and assistance with vendor selection.
  • Ensure project plans are in place prior to first study dosing and that potential study risks are identified and mitigation strategies are implemented
  • Track and monitor trial related documents, leads site initiation visits, ensure GCP and regulatory compliance is maintained, and resolve site(s) issues
  • Monitor the quality of vendor deliverables so that quality, timeliness, and financial expectations are met.
  • Provide support to business development during the awards process and assist address technical or project related questions

What you will bring to the role

  • Experience in managing projects in a multi-office environment
  • Demonstrated ability to handle multiple competing priorities, inspire effective teamwork and motivate team members.
  • Excellent communication, planning and organizational skills; Self-motivated and excellent problem-solving skills 

Your experience  

  • University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
  • Minimum of five(5) years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
  • In lieu of the above requirements, candidates with five (5) years supervisory experience in a health care setting and four (4) years clinical research experience in the pharmaceutical or CRO industries will be considered and/or proven ability and demonstration of relevant experience and skills in clinical development
  • Thorough knowledge of project management processes and ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
  • Available for domestic and international travel, including overnight stays 
  • Valid current passport required
  • Ability to drive and have a valid driver’s license
  • Fluent in English, both written and verbal 

Why Worldwide 

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.    

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

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Employment Type: Regular

Community / Marketing Title: Project Manager - Early Phase Trials

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.