CTA/ Study Start up Specialist

CTA/ Study Start up Specialist (Mumbai Location)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We specialize in translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model revolves around placing the customer and the patient at the core of our operations. We continuously seek ways to simplify and streamline our work to enhance both the ease of collaboration with Syneos Health and the overall experience of working with us.Whether you engage with us in a Functional Service Provider partnership or a Full-Service environment, you will be part of a team of passionate problem solvers collaborating to help our customers achieve their goals. We are agile and committed to expediting the delivery of therapies because we are driven by the desire to make a positive impact on people's lives.Join our 29,000 employees across 110 countries who already understand the significance of:WORKING HERE MATTERS EVERYWHEREWhy Syneos Health:- We prioritize the development of our employees through career growth opportunities, engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.- We uphold a Total Self culture where you can genuinely be yourself. This culture unites us globally, and we are devoted to looking after our people.- We are consistently shaping the company where everyone wants to work and that our customers want to engage with. By embracing diversity of thoughts, backgrounds, cultures, and perspectives, we foster an environment where everyone feels a sense of belonging.CTA/ Study Start-up Specialist (Mumbai Location)Job Responsibilities:- Manage activities related to study start-up and ongoing study document management.- Serve as the point of contact for local study teams and external stakeholders.- Independently handle multiple country, study, and site level deliverables during start-up and maintenance, engaging with both internal and external business partners and vendors as needed.- Strategize and plan start-up activities to ensure successful recruitment and delivery.- Facilitate the preparation of Investigator Sites for clinical trials by reviewing and approving essential clinical trial and regulatory documents.- Assist local regulatory activities by preparing and submitting documents for Health Authorities, including follow-up until approval, and for Ethics Committees, including follow-up until approval.- Collaborate with various internal roles in country feasibility and site selection.- Work closely with internal study teams, external site staff, and country ethics committees/IRB to align tasks and priorities with defined study timelines.- Manage the preparation and approval of country Informed Consent Form (ICF) and ICF template, Site ICFs, Clinical Trial Package (CTP) documentation, and national registries update.- Ensure the electronic Trial Master File (eTMF) contains the relevant CTP regulatory documents for site activation and ongoing study management.- Review and translate drug/IMP labels when applicable.- Stay updated on country regulatory requirements and evolving regulations in collaboration with Regulatory and legal teams.- Provide support for Health Authority inspection, pre-inspection activities, audit preparation, and Corrective Action/Preventative Action preparation for local issues.Qualifications:QUALIFICATION REQUIREMENTS:- Bachelor's degree in Life Sciences or equivalent.- 3+ years of industry experience, including handling trial start-up activities, coordinating trial activities, and submitting to Health Authorities/Ethics Committees.- Profound understanding of GCP, ICH Guidelines, and country-specific regulatory environments.- Thorough knowledge of clinical research processes, regulations, and methodology.- Demonstrated organizational, planning, and decision-making skills.- Experience in leading or participating in cross-functional teams, task forces, or global initiatives.- Strong organization, time management, and prioritization skills with the ability to manage multiple tasks effectively.- Ability for critical thinking and risk analysis.Explore the realm of Syneos Health:- In the past 5 years, we have collaborated on 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.- Regardless of your role, you will be encouraged to take initiative and challenge the status quo in a competitive and ever-evolving environment.Kindly note that the tasks, duties, and responsibilities listed in this job description may not be exhaustive. The Company reserves the right, at its discretion and without prior notice, to assign additional tasks, duties, and responsibilities. Candidates with equivalent experience, skills, and/or education will also be considered, leading to variations in qualifications. Additionally, nothing in this description should be construed as creating an employment contract. The Company is committed to complying with all applicable laws, including the provision of reasonable accommodations under the Americans with Disabilities Act.,
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CTA/ Study Start up Specialist (Mumbai Location)
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