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Clinical Trial Manager I - Site Care Partner

Syneos Health

Client, IndiaFull TimeEntry
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Location
Client, India
Employment
Full Time
Work model
On-Site
Level
Entry
Posted

Skills

AgileGCP

About this role

Clinical Trial Manager I - Site Care Partner Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

7+ years of onsite clinical monitoring experience. Minimum 1 year of hands-on Clinical Trial Project Management experience is mandatory, with exposure to study planning, site oversight, stakeholder management, enrolment tracking, issue escalation, timeline management, and cross-functional coordination. This is a site-focused Clinical Trial Management role requiring regular on-site presence (5 days/week) at Mumbai and active oversight of clinical trial sites, including site performance, compliance, patient enrolment, study milestones, and investigator relationships. Candidates must be willing to travel extensively and spend significant time at investigator sites, acting as the primary liaison between sites, sponsors, and study teams. Applicants seeking primarily office-based project management roles without site management responsibilities may not be a suitable fit for this position. SEC Meeting exposure: In addition to the site management responsibilities, supporting leadership updates by preparing presentations for key stakeholders, communicating site progress, discussing enrolment metrics, escalating site issues, and contributing to study-level action planning and execution. Good experience of Site selection, site initiation, and site activation Client Office based opportunity in Mumbai Should be able to act as the primary point of contact for sites Strong oncology experience is mandatory. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiologic Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each

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