CTA/ Study Start up Specialist

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

CTA/ Study Start up Specialist (Mumbai Location)

Job 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 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.
• 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.
• 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.
  
  

Qualifications

QUALIFICATION REQUIREMENTS

• 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.
• 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.
  
  

Get to know Syneos Health

Over the past 5 years, we have worked with 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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.