Clinical Trial Manager
Chadds Ford, PA
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Manager based in Chadds Ford, Pennsylvania. The CTM will provide input to the overall operational trial(s) implementation process. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality
- Assists in review, development and writing of clinical trial documents and manuals, including Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents
- Select, coordinate and monitor activities of vendors and investigational sites
- Review of monitoring reports and conduct co-monitoring visits
- Develop and manage trial(s) timelines, budget and priorities
- Participate in data review and discrepancy resolution
- Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress
- Generate reports to update management on conduct of trial
- Ensure appropriate clinical trial supply plans are implemented and managed
- Develop recruitment plans, risk-mitigation plan, monitor and implement contingencies
- Participate in monitoring study safety
- Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
- Assist with CRA and third party vendor training on protocols and practices
- Lead the multi-disciplinary trials teams; include the study team meetings
- Function as the primary contact for trial(s) between Drug Development and other departments
- Assume responsibility to participate as a member of a working group and perform special projects
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations
- At least five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory or health authority experience
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
- Bachelor’s Degree with strong emphasis on science
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.