Syneos Health Hiring Clinical Trial Assistant

Join Syneos Health, a leading biopharmaceutical solutions organization, for a rewarding career opportunity. We are seeking a highly motivated individual to join our team as a Clinical Trial Assistant (CTA). Make an impact in the world of healthcare and advance your career with us. Apply now!

Job Title: CTA/ Study Start-up Specialist (Mumbai Location)

Location: India-Asia Pacific – IND-Client-Based, India
Job ID: 23007113

Description: Join Syneos Health®, a leading fully integrated biopharmaceutical solutions organization, as a Clinical Operations Spe. Our innovative approach and dedication to accelerating customer success make us a dynamic workplace.

Responsibilities:

• Responsible for activities related to study start-up and ongoing study document management.
• Act as point of contact for local study teams and external stakeholders.
• Independently manages multiple country, study and site-level deliverables during start-up and maintenance of internal and external business partners and vendors, when required.
• Planned and developed strategy for start-up activities to ensure successful recruitment and delivery.
• Prepare Investigator Sites to conduct clinical trials by reviewing and approving essential clinical trial and regulatory documents.
• Support local regulations in preparing and performing submissions for Health Authorities, including follow-up until a roval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees, including follow-up until approval (protocol, amendments/IB, and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the internal study teams, external site staff, and country ethics committees/IRB to ensure tasks and priorities align with the defined study timelines.
• Prepare country Informed Consent Form (ICF) and manage country ICF template.
• Review and approval of Site ICFs.
• Review and approval of Clinical Trial Package (CTP) documentation.
• Update national registries as applicable.
• Ensures the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
• When applicable, conduct drug/IMP label review & translation.
• Serves as an expert on country regulatory requirements and keeps up to date with evolving regulations in collaboration with regulatory and legal teams.
• It may support collecting and distributing documents from/to sites, including obtaining insurance certificates.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for local-related issues.

Qualifications:

• Bachelor’s degree required, preferably within Life Sciences or equivalent.
• 3+ years of industry-related experience, including handling trial start-up activities, coordination of trial start-up activities and Health Authority / Ethic Committee submissions.
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment.
• In-depth knowledge and understanding of clinical research processes, regulations, and methodology
• Demonstrated organizational and planning skills and independent decision-making ability.
• Experience leading or participating actively in cross-functional teams, task forces, or local and global initiatives.
• Strong organization and time management skills and ability to manage multiple competing priorities effectively.
• Ability of critical thinking and risk analysis.

Apply Now: Apply online

Additional Information:
Tasks, duties, and responsibilities vary. Equivalent experience and skills will be considered. This job description is not exhaustive and does not create an employment contract. Syneos Health is committed to compliance with applicable laws and providing reasonable accommodations when necessary.

Tagged as: Good Clinical Practice (GCP)