Global Trial Leader
East Hanover, NJ
Our client is looking for a highly qualified and skilled professional for the role of Global Trial Leader in East Hanover, New Jersey. We are looking for a Global Trial Leader with at least three years of clinical research experience who wants to be a part of a great organizational culture, is organized and loves the industry.
- Plan, facilitate and lead the global multidisciplinary Clinical Trial Team (CTT)
- Provide direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
- Communicate protocol information including changes or amendments to countries
- Create and implement an operational trial plan with line function support and stake-holder management with tracking to plan and updating as required
- Execute an operational risk management plan highlighting potential risks and actions
- Create and drive trial level timelines
- Ensure all trial deliverables are met (i.e., budget) on time with quality
- Provide updates at relevant internal/external (as applicable) boards
- Prepare all relevant study related documents required for trial initiation with Clinical Scientist (CS)/Medical Lead and line functions to ensure availability of high quality deliverables within specified timelines
- Accountable to write monitoring plan (including any tools and forms) and ensure CSM and medical input
- Plan, drive and facilitate multi-national investigator meetings or equivalent investigator training
- Management of vendor start up, development of data specifications, and oversight of vendor activities and interactions during the trial, including CRO and alliance partners
- Collaborate with drug supply managers to ensure all aspects of the test article are managed throughout the trial
- Manage overall trial conduct to trial close out in coordination with line functions and countries
- Facilitate trial close out activities
- Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process
- Three years technical and operational experience in planning, executing, and reporting clinical trials
- Project Management experience preferred
- Excellent negotiation and conflict resolution skills
- Demonstrated ability to effectively manage trial budget
- Bachelor’s Degree
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.