Project Manager

Princeton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Project Manager in Princeton, New Jersey.  The Project Manager role will oversee all assigned clinical research staff to ensure that clinical study activities are managed in an efficient and effective manner. As they oversee and conduct clinical trial research studies and projects, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity! 

RESPONSIBILITIES

  • Oversee all assigned clinical research staff to ensure efficient and effective management of clinical study activities are maintained  
  • Support proposals and business development as necessary to secure new business by completing activities such as providing review and input to RFPs and presenting at bid defense meetings as requested
  • Coordinate and manage clinical trials from start-up to close-out, within the contractual timelines
  • Conduct specific financial management activities, including but not limited to, contract adherence, budget management, and regular budget reviews with the client
  • Provide study-specific training for the clinical research staff
  • Generate a comprehensive and detailed study-specific Project Plan (PP) and ensure underlying functional plans are included
  • Establish and manage processes to track and analyze critical project information and metrics, including by not limited to, timeline management, project projections and forecasts, and trend and gap analyses
  • Serve as the primary liaison between the clinical study/team and the client
  • Communicate significant issues to the Director of Clinical Operations or other appropriate Operational Leadership
  • Follow applicable Standard Operation Procedures (SOPs)
  • Ensure compliance with applicable GCPs through training, processes, and early issue identification/correction
  • Collaborate with other functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions, and ensure the implementation of timely solutions
  • Develop and implement risk management strategies and contingency plans for clinical deliverables
  • Maintain a flexible approach to addressing issues innovatively and proactively
  • Participate in team, client, and cross functional meetings
  • Provide co-monitoring and mentoring for less experienced CRAs as needed
  • Travel to project sites in order to support completion and oversight of responsibilities, CRA performance, and to help with workloads

EXPERIENCE

  • Extensive experience in overseeing and conducting clinical trial research studies and projects required
  • Experience/Training with the following subjects required: Applicable Standard Operating Procedures, 21 CFR Part 11 and all applicable parts, FDA Guidance Documentations including ICH E6, Drug and Device Development and Approval Process

EDUCATION

  • Bachelor’s Degree or RN required
  • Master’s Degree preferred

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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