Novartis Clinical Data Vacancies - Apply Online

Novartis India Hiring For Clinical Data Specialist Job – Apply Now 

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Novartis Clinical Data Vacancies - Apply Online Novartis India, a leading global pharmaceutical company, is looking for a Clinical Data Specialist in Hyderabad, Telangana. This...
Microbiology jobs at Amneal

Microbiology Jobs at Amneal Pharmaceuticals, Apply for Senior Executive Position!

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Microbiology jobs at Amneal Pharmaceuticals, Apply for Senior Executive position About Amneal India Amneal India is a leading pharmaceutical company committed to improving access to high-quality...
ICGEB MSc Life Sciences Project Vacancies - Apply Now!

ICGEB MSc Life Sciences Project Vacancies – Apply Now!

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ICGEB MSc Life Sciences Project Vacancies - Apply Now! About the Company The International Centre for Genetic Engineering and Biotechnology (ICGEB) was established in 1983 as...
Bioinformatics Jobs at Sanofi - Apply Online Now

Bioinformatics & Data Science Jobs at Sanofi – Apply Online Now

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Bioinformatics Jobs at Sanofi - Apply Online Now About the company Join an innovative global healthcare company - Sanofi, where progress meets extraordinary. At Sanofi, we...
Senior Analyst Data Management Job In Bangalore - Merck KGaA is Hiring - Apply Online!!

Join Merck KGaA as a Senior Analyst in Data Management – Apply Now!

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Merck Data Management Analyst Jobs - Apply Now Merck KGaA is hiring a Senior Analyst in Data Management in Bangalore, India! If you have expertise...
Sr. Executive Microbiology Role Opportunity

Sr. Executive Microbiology Role at Zentiva, Apply Now!

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Sr. Executive Microbiology Role - at Zentiva, Apply Now! Zentiva is seeking a Sr. Executive – QC, Microbiology for its Ankleshwar, India facility. If you...
Schrödinger Technical Writer - ScienceComputational Chemistry Graduates Apply Now

Schrödinger: Technical Writer – Biochem/Biophysics Apply Now

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Schrödinger: Technical Writer - Science/Computational Chemistry Graduates Apply Now Schrödinger is a leading company at the forefront of computer-aided drug discovery and materials science. Our...
Healthcare Research & Data Analyst Job Clarivate Careers is hiring Life Science Candidates - Apply Now!!

Join Clarivate as an Associate Healthcare Research & Data Analyst in Bangalore – Apply...

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Healthcare Research & Data Analyst Job | Clarivate Careers is hiring Life Science Candidates - Apply Now!! Clarivate is hiring an Associate Healthcare Research &...
Business Development Manager Job

Exciting Business Development Manager Opportunity at Thermo Fisher Scientific!

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Business Development Manager Job - – Synthetic Biology at Thermo Fisher, Apply Now! Are you an experienced business development professional with a passion for synthetic...
ILS JRF Biotechnology Job Opening

JRF Leading to PhD at Institute of Life Sciences (ILS), Apply Online

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ILS JRF Biotechnology Job Opening - Apply Now Advt. No. 10/2025 Date: 01.04.2024 Institute of Life Sciences (ILS), Bhubaneswar, an autonomous institute of the Department of...
NII Bioinformatics Project JRF Job

BRIC-NII Bioinformatics Project JRF Job – Applications Invited

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NII Bioinformatics Project JRF Job - Applications Invited BRIC-NATIONAL INSTITUTE OF IMMUNOLOGYNEW DELHI ADVERTISEMENT FOR WALK-IN-INTERVIEW Name of the Position: Junior Research Fellow (Project) (One position only) Duration:...
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!

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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!...
Project Associate-I & Project Assistant Roles Opportunity

ARI Pune Jobs 2025 – Project Associate-I & Project Assistant Roles, Apply Now!

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ARI Pune Jobs 2025 - Project Associate-I & Project Assistant Roles, Apply Now! Agharkar Research Institute (ARI) invites applications for Project Associate-I and Project Assistant...
Executive Biocompatibility Preclinical Studies

Dream Executive Job in Medical Device Company MERIL – Apply Now!

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Executive Biocompatibility Preclinical Studies - at MERIL, in Gujarat. Apply Now! MERIL is hiring an Executive – Biocompatibility & Preclinical Studies in Pardi, Gujarat! If...
PGIMER Clinical Research Coordinator Job

PGIMER Clinical Research Coordinator Job For MSc Life Sciences, Apply Now

Diluxi Arya - 0
PGIMER Clinical Research Coordinator Job For MSc Life Sciences, Apply Now POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCHCHANDIGARH - 160 012Department of Otolaryngology and Head-Neck...
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