Clinical Trial Manager
Our client is looking for an experienced Clinical Trial Manager (CTM) for a 6-month project with the probability of extension. The Clinical Trial Manager role is located onsite in New Jersey and is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The CTM leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials. If you are an experienced CTM, this position could be the next great step in your career.
- Develops and coordinates clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget
- May participate in project core team meetings
- Provides regular and timely input to the assigned Project Manager
- Reviews and contributes to protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs)
- Develops informed consent documents
- Coordinates the qualification and selection of investigative sites, plans for and presents at Investigator Meetings, develops other site training materials
- Develops clinical trial timelines, enrollment projections, documents and instructional materials
- Participates in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection
- Manages vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables
- Responsible for ensuring the development and updating of cost estimates at the study and project level
- Partners with the Clinical Services Partnership (CSP) team in developing complete clinical trial external cost estimates (sites and vendors) and maintains responsibility for the management of the clinical trial budget
- Ensures CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits, and initiates/follows up/tracks significant or relevant project issues at investigative sites
- Ensures study execution compliance with GCP/ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits
- Partners with the Clinical Trial Associate to ensure the TMF is developed, maintained, and archived
- Minimum of 5 years of directly related experience required
- Clinical research experience strongly preferred
- Monitoring, study coordination, data management or clinical project management experience including vendor and CRO management is required
- Prefer experience with opioid analgesics late stage trials, phase 2-3
- Osteoarthritis experience highly desirable
- Bachelor’s Degree required
- BSN/RN, or Bachelor's Degree in a science background preferred
- BA or AS degree considered with commensurate 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.