Clinical Trial Manager/Cep Clinical Trial Manager (Cep Ctm)

Clinical Trial Manager/CEP ClinicalTrial Manager (CEP CTM)
Bridgewater, NJ
Sanofi 4094507
Summary:
The Clinical and Exploratory Pharmacology (CEP) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology Clinical Trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. The CTM is involved in the operational planning and scientific conduct of the Clinical Trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the CEP Data Manager (DM) and Clinical Study Director (CSD).
The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The CTM may also participate in intra or inter-department Working Groups.
Knowledge and skills:

• Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines
• General understanding of R&D processes including the principals of study design and execution
• Capability of interacting effectively with scientists and managers from various disciplines on an international basis
• Ability to serve as internal consultant on assigned area and liaise with external organizations on projects
• Good interpersonal and communication skills (verbal and written)
• Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented
• Ability to build optimal collaboration within the company and with external partners
• Ability to work in a team environment
• Project Management skills
• Experience with various computer systems/database; a willingness to learn new systems/databases
• Ability to prioritize activities
• Results-driven in terms of timelines and quality

Education and Experience Required:
United states:
Bachelor's Degree + 8+ yrs. laboratory or medical experience
5+ years in clinical research
Europe:
Client +4/5 (Master's Degree)
5+ years minimum in clinical research, including an international background
Field monitoring experience or related experience is required (approximately 3-5 years).
Strong English communication skills (verbal and written) if English is a second language.
Clinical Trials Management or Project management experience (approximately 3-5 years) and recognized in cross functional operations.
Knowledge And Skills Desirable But Not Essential:
Previous Phase I experience preferred
Knowledge of data management activities
Experience with management of outsourced activities
Major Duties and responsibilities:

• Provide management and oversight of Clinical Trials (which may include complex, multiple center and multinational proof-of-concept studies) to ensure progress according to study timelines.
• Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).
• Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level.
• Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).
• Anticipate bottlenecks in all steps of the study and development/implementation of counteractive measures
• Solve or coordinate the resolution of issues during conduct of the trial
• Develop and review specific study-related documents
• Develop and coordinate the study budget, including invoice validation
• Contribute to contract process
• Manage investigational product supplies (ordering, packaging, and shipment)
• Participate in and contribute to internal audits, if applicable
• Serve as main contact for clinical sites and other outsourced activities
• Manage local MT (CSUs) when applicable
• Manage outsourced centralized activities when applicable (Central Lab)
• May perform studies following some Phase 2-3 processes when applicable (multicenter-multicountry Phase 2a trials)
• Collect, synthesize, report, file and prepare archiving for Clinical Trial activities.
• Manage CRO/study sites
• Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions
• Assess CRO performance by completing CRO post services assessments
• Conduct yearly CRO assessment, if applicable