Senior Specialist, Clinical Trial Management

Job Description

The Position

The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in the operational aspects of phase 1 & phase 2a studies and will report to the Executive Director, TMED Operations.  The CTM will support the TMED Operations Lead to plan and execute studies including, but not limited to, managing study timelines, reviewing/approving study-related documents and serving as the primary point of contact for study vendors.  The CTM will also assist to manage the clinical study team and help to coordinate meetings and interactions with vendors to optimize communication and execution of TMED studies.

Responsibilities

• Manage and support the operational aspects of clinical studies from study start-up through close-out.

• Manage and serve as the point of contact for study-related vendors, including the study contract research organization (CRO) and/or clinical study sites or other vendors, as appropriate, to execute TMED studies in accordance with contracted scope, costs and timelines.

• Actively engage with vendors on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities.

• Coordinating internal and external cross-functional communication and documentation to optimize collaboration and ensure TMED studies are executed with the highest standards and are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. 

• Identify risks to ensure successful execution of TMED studies, proactively communicate risks to internal and external cross-functional teams and vendor teams, and manage the clinical study team to develop and implement risk mitigation strategies and tactics to enable study completion in accordance with approved timelines and plans.

Tasks

• Attend and actively participate in assigned clinical study teams and vendor meetings.

• Oversee vendor and CRO performance, ensuring deliverables are met within scope, budget, and quality standards.

• Engage and communicate effectively with study site personnel and investigators.

Competencies

• Phase 1 study operations

• ICH/GCP

• Clinical research 

• Clinical development

• Vendor selection and management

Required Education, Experience and Skills

• Bachelor’s degree or higher in natural or health sciences (pharmacology, biology, nursing, or related sciences).

• Excellent organizational and project management skills to facilitate optimal clinical study team and/or sub-team functioning and cross-functional collaboration.

• Working knowledge of GCP, ICH and other regulatory standards.

• Skillful at technical writing with an ability to precisely and accurately summarize clinical and scientific information in written format.

• Track record of effective functional representation on product development teams.

• Excellent verbal and written communication skills.

• Collaborative mindset with a positive, transparent and inclusive approach as a representative or leader of cross-functional team(s).

• Functional capability with various software platforms including Microsoft Word, PowerPoint, and Excel.

• A minimum of five to six years-experience in translational medicine and early clinical development within the pharmaceutical or biotech industry with a proven track record for competence and efficiency in overseeing the execution of TMED (early phase 1 – 2a) studies.

• Experience supporting the early development function by contributing to SOP working groups and other process-related teams and/or sub-teams.

• Experience in Women’s Health is strongly preferred.

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Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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