Job Description

Description

Sr Clinical Operation Specialist (CTA , Client based - Mumbai Location))
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.


Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.


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 accelerate the delivery of therapies, because we are passionate to change lives.


Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

Role Summary:

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A detail-oriented and process-driven professional responsible for the end-to-end management of PSDS/MAP programs, including regulatory submissions for medical affairs studies and related activities such as support publications and vendor onboarding. The role involves close coordination with internal stakeholders (Medical Leads, Study Managers, Regulatory Affairs, and Patient Safety) as well as external partners (CROs and other vendors). Additionally, the position oversees comprehensive drug supply management for studies and MAP/PSDS programs while ensuring accurate documentation and compliance with regulatory and organizational standards.

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Key Responsibilities:

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1. PSDS/MAP Management:

Support in creating new user/physician accounts in GEMS system and ensure smooth onboarding for PSDS/MAP request submissions. Review and assess PSDS/MAP requests in GEMS; coordinate CMR/GMR for approval process. Draft and coordinate MAP/PSDS agreements until finalization. Prepare and distribute MAP/PSDS documents to the physicians. Coordinate with physicians for the required documents & Supply teams for MAP/PSDS approvals and drug supply. Generate institute codes for local supply logistics. Manage and share initial and updated PSDS/MAP documents with physicians. Provide guidance and training on MAP/PSDS Management & to the physicians/Teams & Medical associates. Update GEMS with relevant documents (Document archival) for PSDS/MAP requests. Coordinate with Global MAP/PSDS team for the drug forecasting & other relevant processes. Attend and contribute to global and local meetings for PSDS/MAP/Study updates.

2. Local MA Studies- Interventional/Non Interventional/Research Collaboration

Manage end to end CTRI submissions/registrations of MA studies including addressing queries, and communication with the CTRI team. Coordinate & submit documents to Regulatory team for local studies & other MA activities, including QSR and DCGI dossiers. Liaise with CROs for study documentation and activity coordination. Support self-assessment activities for MA activities. Manage local drug conversion processes for MA studies. Prepare and finalize Drug Conversion Forms (FRMs). Coordinate with supply team and external partners/clinical trial sites for supply related requests. Maintain & Archive related documents and manage supply chain communications. Create and maintain Repository-Subway/NCV folders. Ensure proper clinical trial document archival within electronic repository. Maintain document updates for regulatory and operational needs.

3. Financial & Vendor Coordination

Review and process invoices related MA activities. Support publication activities by coordinating with physicians & vendors Support for vendor onboarding & qualification including agreement finalization and sign-off process.

Key Skills:

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Clinical trial operations Medical Operations Regulatory document management Clinical Trials system proficiency Cross-functional coordination Documentation and archival Strong communication and organizational skills

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.


No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.


http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Operations at the S11 level are responsible for ensuring the safe and effective operations of clinical research studies. This includes safeguarding the wellbeing of research subjects in a medical capacity, reviewing study protocols, and executing procedures in alignment with protocols and regulatory, health, and safety standards. These roles involve recruiting and coordinating communication with clinical trial volunteers and patients, and following applicable regulations globally and by region. Collaboration with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study is also a key aspect of these roles.Impact and ContributionRoles within Clinical Operations at the S11 level significantly contribute to the success of clinical research studies by ensuring that all operations are conducted safely and effectively. By safeguarding the wellbeing of research subjects and adhering to regulatory standards, these roles help maintain the integrity and reliability of clinical trials. The coordination and communication with clinical trial volunteers and patients ensure smooth and efficient study progress. Collaboration with cross-functional teams enhances the development of study materials and the resolution of any issues, ultimately contributing to the advancement of medical research and the development of new treatments.Core FocusoSafeguarding the wellbeing of research subjects in a medical capacityoReviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standardsoRecruiting and coordinating communication with clinical trial volunteers and patientsoFollowing applicable regulations globally and by regionoCollaborating with cross-functional teams to develop study materialsoMonitoring trial progress and addressing any issues that arise during the studyoProviding organizational related support or service, typically under supervisionoPerforming routine tasks with some deviation from standard practiceoUtilizing broad knowledge of operational systems and practices gained through extensive experience and/or education