Clinical Trial Leader
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Trial Leader in Cambridge, Massachusetts. The Clinical Trial Leader will function as the lead on the planning and implementation of all operational aspects of assigned Translational Medicine clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM)
- Author of the clinical study protocol and other study essential documents
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
- In collaboration with outsourcing/planning/feasibility personnel, CTT, local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and Site Initiation meeting(s)
- Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
- Oversee the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
- Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, Management, Project team representatives and others
- Regularly update all trial information databases in order to manage accuracy of information
- Review and approve all study payments as per financial agreements
- Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
- Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high quality data are transferred and available in a timely manner
- Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing and narrative group to ensure report is completed according to current requirement
- Responsible for report publication
- In collaboration with the Medical Expert and CTT, coordinate the ongoing medical or scientific review of the clinical trial data
- Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions
- Oversee the work of assigned support CTL(s), ensuring clear delegation and assignment of duties are documented
- Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies
- Provide operational expert advice to other departments and line functions (e.g. QA, Drug Metabolism and Pharmacokinetics, Drug Supply Management)
- Maintenance of knowledge and training of ICH-GCP, current regulations and procedures
- Relevant experience in clinical trials or drug development (e.g. study management in a multinational environment using different models for trial execution)
- Bachelor’s of Science or Master’s of Science in life sciences or nursing
- PhD level scientist with life sciences background
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.