▷ (Only 24h Left) Sr Clinical Operation Specialist (cta , Client Based - Mumbai Location))

Updated Yesterday Location Pune MH India Job ID 25102667 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 youa 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 a 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 a wea re able to create a place where everyone feels like they belong Job Responsibilities Role Summary 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 Key Responsibilities 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 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 youa ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health 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 Contribution Roles 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 Focus a Safeguarding the wellbeing of research subjects in a medical capacity a Reviewing study protocols and executing procedures in alignment with protocols and regulatory health and safety standards a Recruiting and coordinating communication with clinical trial volunteers and patients a Following applicable regulations globally and by region a Collaborating with cross-functional teams to develop study materials a Monitoring trial progress and addressing any issues that arise during the study a Providing organizational related support or service typically under supervision a Performing routine tasks with some deviation from standard practice a Utilizing broad knowledge of operational systems and practices gained through extensive experience and or education Share this job