Syneos Health BSc Jobs For Life Sciences, Apply For Study Start Up Job Syneos Health is hiring a CTA/Study Start-Up Specialist for its Mumbai location! This role involves clinical trial documentation, regulatory submissions, ethics committee coordination, and site activation. If you have 3+ years of experience in trial start-up activities, a strong understanding of GCP/ICH guidelines, and excellent organizational skills, apply today to join a globally recognized clinical research organization. Job Title: CTA/ Study Start up Specialist (Mumbai Location) Location: India-Asia Pacific - IND-Client-Base Why Join Syneos Health: Passionate about employee development Supportive and engaged line management Total Self culture promoting authenticity Focus on creating a diverse and inclusive work environment Job Responsibilities for CTA/ Study StartUp Specialist: 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 both internal and external business partners and vendors, when required. Plan and develop strategy for start-up activities to ensure successful recruitment and delivery. Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents preferred for Study StartUp Specialist. Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval.  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, country ethics committees/IRB to ensure tasks and priorities are aligned to 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 that 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 required for Study StartUp Specialist. Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal. May support the collection and distribution of 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. Qualification Requirements for Study StartUp Specialist: Bachelor's degree required, preferably within Life Sciences or equivalent. 3+ years of industry related experience, including handling of 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 as Study StartUp Specialist. Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Ability of critical thinking and risk analysis. APPLY ONLINE HERE  Keywords: CTA, Study Start up Specialist, Mumbai Location, Job, Syneos Health, Job Posting. Syneos Health BSc Jobs For Life Sciences, Apply For Study Start Up Job
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Syneos Health BSc Jobs For Life Sciences, Apply For Study Start Up Job

Syneos Health is hiring a CTA/Study Start-Up Specialist for its Mumbai location! This role involves clinical trial documentation, regulatory submissions, ethics committee coordination, and site activation. If you have 3+ years of experience in trial start-up activities, a strong understanding of GCP/ICH guidelines, and excellent organizational skills, apply today to join a globally recognized clinical research organization.

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

Location: India-Asia Pacific – IND-Client-Base

Why Join Syneos Health:

  • Passionate about employee development
  • Supportive and engaged line management
  • Total Self culture promoting authenticity
  • Focus on creating a diverse and inclusive work environment

Job Responsibilities for CTA/ Study StartUp Specialist:

  • 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 both internal and external business partners and vendors, when required.
  • Plan and develop strategy for start-up activities to ensure successful recruitment and delivery.
  • Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents preferred for Study StartUp Specialist.
  • Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval.  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, country ethics committees/IRB to ensure tasks and priorities are aligned to 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 that 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 required for Study StartUp Specialist.
  • Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal.
  • May support the collection and distribution of 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.

Qualification Requirements for Study StartUp Specialist:

  • Bachelor’s degree required, preferably within Life Sciences or equivalent.
  • 3+ years of industry related experience, including handling of 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 as Study StartUp Specialist.
  • Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.
  • Strong organization and time management skills and ability to effectively manage multiple competing priorities.
  • Ability of critical thinking and risk analysis.

APPLY ONLINE HERE 

Keywords: CTA, Study Start up Specialist, Mumbai Location, Job, Syneos Health, Job Posting. Syneos Health BSc Jobs For Life Sciences, Apply For Study Start Up Job

Shekhar
Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.

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