Clinical Trial Manager
Jersey City, NJ
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Manager (CTM) in Jersey City, New Jersey. The CTM role is responsible for supporting the Senior or operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget). Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Collaborating with clinical affairs and other functions, and responsible for the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
- Responsible for the execution and adherence of the study operational plan (start up, conduct, close-out, and vendor oversight) including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRIs SOPs and policies
- Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation
- Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools
- Responsible for supporting the management and maintenance of the study TMF
- Supports the Sr. CTM in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders
- Minimum of 3 to 5 years of pharmaceuticals/biotech experience
- Minimum of 3 to 5 years drug development experience in the pharmaceutical industry or CRO or commensurate clinical or medical research experience with emphasis on Phase II-IV clinical trials
- Program and project management experience preferred.
- Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections
- Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics
- Clinical trial management system (CTMS) background, International experience a plus
- Bachelor of Science 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.