We are currently searching for a skilled professional to join a well-known client's team as a Clinical Trial Lead in Princeton, New Jersey. The Clinical Trial Lead role will act as the operational lead for assigned domestic and global protocol(s) to ensure proper conduct and timely completion of project(s). Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Contribute to the development and implementation of clinical trial strategy
Serve as primary contact/resource to External Service Providers (ESPs) for day-to-day protocol-related issues and propose solutions to maintain project within designated budget and timelines
Oversee the development of study-related documents, trial planning, recruitment strategy, site selection, and trial execution according to plan
Manage and lead team meetings
Report accurate trial-related information (enrollment, monitoring, regulatory documents, etc.), trend analysis, and risk mitigation
Review and analyze the data from tables and listings
Coordinate training programs for clinical trial staff and ESPs prior and during study conduct
Train the ESP in internal/company clinical data review
Identify and escalate potential serious compliance issues and assist in the development of action plans
Communicate and coordinate study-related activities across all relevant cross-functional areas
Ensure assigned studies are conducted following the protocol, ICH, GCP, and all applicable global regulatory requirements
Conduct Monitoring Oversight Visits
Approve selection of appropriate clinical staff by the ESP
Encourage communication and interaction within project team
Participate in process and continuous improvement initiatives
Serve in the Oversight Risk Management role, when assigned
Perform regular reviews within the eSource and eSurveillance systems per the Oversight Risk Plan (ORP) and Integrated Data Review Plan (IDRP) to oversee and ensure quality performance throughout the life cycle of the trial
Track and analyze data for trending, develop appropriate action plan for risk mitigation strategies, and report outcomes (issues/trends) to the clinical trial team
Analyze qualitative and quantitative metrics from remote and onsite monitoring visits addressing and resolve issues through risk mitigation strategies
Implement the ORP and the Trial Master File (TMF) Plan for assigned trials
Support Clinical Trial Team (CTT) in preparing for internal/external audits and develop or assist in the implementation and management of CAPAs
Join in User Acceptance Testing (UAT) for assigned trial to ensure technology integration is in alignment with the trial protocol
EXPERIENCE
Minimum of 5 years of experience in the pharmaceutical industry required
Minimum of 3 years of experience in leading multidisciplinary clinical trial teams from final protocol to database lock (DBL)
Travel required - up to 30%
Ability to articulate complex ideas in understandable business terms to all levels of leadership and project teams required
EDUCATION
Minimum of Bachelor's Degree or Registered Nurse (RN) required
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.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
