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Pharmacovigilance Project Lead at ICON plc | Apply Now!

Shekhar - April 3, 2025 0

Pharmacovigilance Project Lead at ICON plc | Clinical Research Jobs In India - Apply Now!! Are you passionate about drug safety and regulatory compliance? ICON...

Biotecnika Times Newsletter 01.04.2025 – Freshers Jobs at Syngene, Labcorp, Admissions Open at MIRM...

BioTecNika Bureau - April 1, 2025 0

BioTecNika Info Labs Pvt Ltd | Established 2006 | For you BioTecNika Times ONLINE | BANGALORE 18 Years of Service dedicated to Bio Professionals & Biotech Industry /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// All India Toll Free Ph:...

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

Syneos Health BSc Life Sciences Study Start up Specialist Position Available Now!

Shekhar - April 1, 2025 0

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!...

Biotecnika Times Newsletter 31.03.2025 – High Paying Jobs at NCBS, inStem & AIIMS Delhi,...

BioTecNika Bureau - March 31, 2025 0

BioTecNika Info Labs Pvt Ltd | Established 2006 | For you BioTecNika Times ONLINE | BANGALORE 18 Years of Service dedicated to Bio Professionals & Biotech Industry /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// All India Toll Free Ph:...

ICON plc Medical Writer Jobs for Life Sciences – Apply Now!

Shekhar - March 31, 2025 0

ICON plc Medical Writer Jobs for Life science graduates ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an...

Biotecnika Times Newsletter 28.03.2025 – Freshers Jobs at C-CAMP, FSSAI Internship, Bharat Serums &...

BioTecNika Bureau - March 28, 2025 0

BioTecNika Info Labs Pvt Ltd | Established 2006 | For you BioTecNika Times ONLINE | BANGALORE 18 Years of Service dedicated to Bio Professionals & Biotech Industry /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// All India Toll Free Ph:...

Data Coordinator at Medpace – BSc Life Sciences Apply Now!

Shekhar - March 28, 2025 0

Data Coordinator at Medpace - Apply Now! Join Medpace, a leading global CRO (Contract Research Organization), as a Data Coordinator in Navi Mumbai, India. If...

Pharmacovigilance Specialist, Case Processing - Job Opportunity

Pharmacovigilance Specialist at ProPharma – Apply Now!

Shekhar - March 28, 2025 0

Pharmacovigilance Specialist at ProPharma - Apply Now! Join ProPharma, a global leader in regulatory sciences, clinical research, and pharmacovigilance. We are hiring a Pharmacovigilance Specialist...

Join ICON as Pharmacovigilance Reporting Associate Now!

MP Sandhya - March 28, 2025 0

Pharmacovigilance Reporting Associate at ICON plc | Apply Now Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Pharmacovigilance Reporting Associate...

Biotech Job Placement for Freshers & Experienced Webinar Conducted Successfully

5 HR’s Under One Roof LIVE on Biotecnikar: Biotech Job Placement for Freshers &...

BioTecNika Bureau - March 28, 2025 0

Biotech Job Placement for Freshers & Experienced Webinar Conducted Successfully Date- 26/03/2025 City- Bengaluru State – Karnataka, India Bangalore, India – On March 26, 2025, Biotecnika successfully hosted...

Biotecnika Times Newsletter 27.03.2025 – Freshers Jobs at Syngene, CuraTeQ Biologics & Clarivate, Summer...

BioTecNika Bureau - March 27, 2025 0

BioTecNika Info Labs Pvt Ltd | Established 2006 | For you BioTecNika Times ONLINE | BANGALORE 18 Years of Service dedicated to Bio Professionals & Biotech Industry /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// All India Toll Free Ph:...

Site Contracts and Budget Associate Job Opportunity

Site Activation Associate IQVIA – BSc Life Sciences Apply Now!

Shekhar - March 27, 2025 0

Site Activation Associate IQVIA - Apply Now! Join IQVIA, a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We are dedicated...

Biotecnika Times Newsletter 26.03.2025 – Freshers Jobs at Biocon Limited, Micro Labs, Fortrea &...

BioTecNika Bureau - March 26, 2025 0

BioTecNika Info Labs Pvt Ltd | Established 2006 | For you BioTecNika Times ONLINE | BANGALORE 18 Years of Service dedicated to Bio Professionals & Biotech Industry /////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// All India Toll Free Ph:...

Safety Operations Associate Manager Opportunity

Safety Operations Associate Manager at IQVIA, Apply Now!

Shekhar - March 26, 2025 0

Safety Operations Associate Manager at IQVIA, Apply Now! Join IQVIA, a global leader in clinical research, pharmacovigilance, and healthcare intelligence, as an Associate Manager, Safety...

Fortrea Life Science Apprentice Program – Apply Online

Sanjana D - March 25, 2025 0

Fortrea Life Science Apprentice Program - Apply Online India Apprentice Program: Embark on a rewarding journey with the Fortrea India Apprentice Program! This program offers a...

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