Senior Clinical Trial Manager 
Remote throughout Europe

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

OVERVIEW

Advanced Clinical is currently searching for a skilled professional to join a well-known client’s team as a Senior Clinical Trial Manager in Europe. Their work will have a direct impact on not just the organization but the larger clinical research industry making this an amazing career opportunity

The Sr. Clinical Trial Manager provides input to the overall operational trials(s) planning and implementation, manages program(s) timelines and budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and external vendors. Leads multidisciplinary department initiatives and provides support for process changes to increase efficiency in study execution. Trials include, but are not limited to, rollover (extension) clinical trials, closing and terminating clinical trials, continued access/post-trial access programs, and late-phase post-marketing trials.

Summary of the Essential Functions of the Job

• Deliver Trials(s) on time, within budget, and with highest achievable quality.
• Assist in the review, development and/or writing of clinical trial documents and manuals as needed, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites for applicable clinical trials, responsible for feasibility.
• Select, coordinate, and monitor activities of vendors.
• Review of monitoring reports and conduct co-monitoring visits, as needed.
• 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 progress of the clinical trial(s)
• Ensure appropriate clinical trial supply plans are implemented and managed where appropriate
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Participate in monitoring study/program 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 vendor training on protocols, guidelines, and/or practices.
• Lead multi-disciplinary trial teams, including the study team meetings.
• Function as the primary contact for program(s) between Drug Development and other departments.
• Participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effectiveness and quality of the functioning of the Development Operations Department.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

Minimum Requirements

• BS/BA degree or a relevant degree with strong emphasis on science or equivalent experience.
• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management, and especially closeout and termination of multinational clinical trials with a focus on skills and competencies rather than specific years of experience.
• Experience in the biopharmaceutical industry or other relevant global clinical research programs in the initiation and management of continued access/post-trial access programs
• Ability to manage complex and/or large clinical/medical programs.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Ability to effectively manage multiple priorities across several programs and therapeutic areas simultaneously.
• Demonstrated leadership and problem-solving skills.
• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
• Experience with lean six sigma concepts and methodologies is preferred
• Experience with medical affairs is preferred
• Used to work in a multidisciplinary setting, strong collaborative team player, ability to be flexible and adapt to a changing environment.
• Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
• Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.