Clinical Trial Manager
East Hanover, NJ
Our client needs a Clinical Trial Manager who sees the world differently. We’re looking for professionals with experience in clinical research who don’t see obstacles but opportunity when it comes to this industry. The Clinical Trial Manager position is responsible for all operational aspects of one or more clinical trials under the leadership of the Clinical Trial Head and is located in East Hanover, New Jersey. We’re looking for problem solvers, innovators, and those inspired by the work we do in making a difference today and with future generations.
- Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
- Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing
- Prepare training materials and presentations related to the planning and conduct of the trial
- Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
- Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations
- Accountable for accuracy of trial information in all trial databases and tracking systems
- Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD
- Participate in the organization and logistics of various oversight and Advisory boards; attend meetings
- Point of contact for managing/answering questions related to trial procedures and patients eligibility
- Write CTT meeting minutes
- May occasionally deputize for the CTH at Clinical Trial Team meetings
- May participate in International Clinical Team meetings
- Contribute to program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
- Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned
- Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities
- May serve as faculty member for OGD training programs
- 2 years of experience in Clinical Research preferred
- Basic knowledge of oncology and/or hematology preferable
- Involvement in cross-functional, multicultural and international clinical trial teams
- Proven networking skills and ability to train colleagues
- Knowledge of Good Clinical Practice
- Knowledge of Clinical Trial Design
- Understanding of the overall drug development process
- Knowledge of principles for trial budgeting
- Advanced Degree in life science or healthcare required
- Bachelor’s Degree in life science or healthcare required, or equivalent education/degree if accompanied with 4 years of experience
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.