Clinical Trial Manager

Seuss Consulting - USA - Senior/Clinical Trial Manager Job Summary The (CTM) provides operational expertise and leadership in the planning, implementation, and management of clinical trials through all periods of trial conduct. delivery of clinical deliverables. All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules, and guidance. Essential Duties and Responsibilities Serves as the primary clinical contact for both the Client and company project team members. Serves as the primary point of contact for the clinical study team. Provides leadership throughout and maintains effective communication at all times. Works in collaboration with Project Management and functional project leads in the execution of clinical trials. Defines and implements study-specific standards, goals, and expectations for the clinical study team. Coordinates, facilitates, and conducts training for clinical study teams as required. Addresses ongoing training needs throughout the study and ensures all trial-specific training is documented appropriately. Ensures completion of clinical activities within agreed timelines. Ensures adherence to the Clinical portion of the project budget; identifies and consults with Project Management on clinical tasks that are out of scope. Oversees the quality and ensures compliance with project specific plans for all clinical deliverables; works with Project Management to identify and mitigate associated risks. Oversees site assignments and ensures clinical resources are continuously adequate. Participates in appropriate external study meetings, including both client and investigator meetings. Prepares and presents as required. Coordinates and leads clinical meetings. Prepares agenda and minutes as required. Develops and maintains clinical study documents, templates, plans and manuals. These include, but are not limited to, the Clinical Monitoring Plan, Study Reference Manual, and associated appendices. Develops, maintains, and oversees trial specific tools to support the clinical operations team. Maintains oversight of site selection and activation activities. Ensures appropriate tracking throughout. Effectively interprets and reports on clinical progress and associated metrics. Ensures applicable trial-related information is tracked and maintained in CTMS as required. Oversees the set-up and maintenance of the clinical portion of the trial master file (TMF). Communicates with the Project manager and/or Line Manager as required, escalating issues of importance where appropriate. Tracks and reviews monitoring visit reports and ensures standards for monitoring and reporting are met; ensures appropriate and timely follow up on open action items. Maintains and reviews protocol deviation tracking ensuring standards for reporting are met. Establishes an effective and collaborative working relationship with external vendors as appropriate, identifying both responsibilities and process. Provides input to clinical proposals, budgets, and contracts. Supports Business Development in preparing for and attending Bid Defense meetings. Conducts accompanied field assessment visits with CRAs as appropriate. Serves as Global CTM for international studies, as necessary. Provides mentoring and/or oversight of less experienced CTMs and/or other members of the clinical department. DEGREE & EXPERIENCE OR equivalent combination of studies, nursing qualifications and/or work experience. 7+ years relevant clinical research experience, including 3-5 years in a CTM or equivalent role. Demonstrated significant experience in the clinical management of studies. SPECIFIC KNOWLEDGE In-depth working knowledge of current ICH-GCP guidelines and applicable regulations. Thorough knowledge of clinical research process. SKILLS Strong communication skills including effective verbal, written and presentation skills; English + local language, if relevant. Demonstrated ability to lead, mentor and provide clinical guidance to team members. Well-developed organizational skills in a complex and fast-paced environment. Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer, and PowerPoint. Physical & Mental Demands This position requires the ability to perform varied tasks, to maintain an appropriate work pace, to exercise logic and reasoning, to comprehend and follow instructions. Performing the duties of this job regularly involves speaking and listening, repetitive hand movement (at least 15 minutes), sitting, standing, walking, reaching, grasping, and lifting up to 10 pounds. Specific vision abilities include close vision and the ability to adjust focus. This position requires the ability to travel 30-50%.... - Permanent - Full-time

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