Clinical Trial Lead

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 Clinical Trial Lead in Princeton, New Jersey.  The Clinical Trial Lead role will demonstrate their leadership by developing and executing the Clinical Monitoring Plan, training the members of their Clinical Research Team when needed, and providing oversight to the daily clinical trial functions (including but not limited to: weekly status reports, budget monitoring, and compliance with SOPs and other applicable industry standards). As they lead client-facing operations as well, their work will have a direct impact on not just the organization but the larger clinical industry—making this an amazing career opportunity!

RESPONSIBILITIES

  • Develop and execute the clinical monitoring plan (CMP)
  • Participate in site identification, recruitment, qualification, and selection
  • Manage site activation, site maintenance, and site closure
  • Conduct CRA training and site training, including direction and mentoring to CRAs and support staff as appropriate
  • Develop site materials, trackers, and logs necessary to track and document deliverables
  • Write study specific plan for release of IP
  • Create study specific templates, including developing ICF template
  • Oversee projection of planned site activation and SIVs
  • Develop contents of investigator site file, site operations manual, and pharmacy manual
  • Review and monitor visit reports
  • Track actual vs. projected variables, as well as parameters related to CRA and site activities
  • Prepare weekly status reports and establish study milestones to ensure accurate tracking and reporting of study metrics
  • Operate in compliance with cGCPs, country specific regulations, ICH Guidelines and SOPs
  • Provide input and manage clinical trial budgets and staffing/resourcing plans
  • Lead daily client-facing operations including bid-defense meetings, kick off meetings, and investigator meetings

EXPERIENCE

  • Extensive experience leading the execution of clinical trials at the site level
  • Working experience with operating in compliance with cGCPs, country specific regulations, ICH Guidelines and SOPs in the pharmaceutical industry

EDUCATION

  • Bachelor’s Degree required, preferably in biological sciences, healthcare, or pharmacy medicine
  • Additional training/certifications in a related field 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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