Clinical Support Specialist (Hyderabad location)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

• Min 1-2 yrs of relevant exp
• Should be flexible with EMEA time Zone  
• Must have TMF filing, QC, site contract experience
• Should have strong English communication and MS office skills

JOB RESPONSIBILITIES

• Performs activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and GCP & ICH Guidelines.
• Maintains timely and effective communication with study team regarding assigned task & deliverables.
• Performs assigned activities that support study maintenance such as but not limited to:
  • Maintenance of Trial Master File (TMF), perform TMF document process activities applicable for PTSC.
  • TMF completeness reviews as requested by TMF Operations.
  • Maintenance of Syneos Health clinical applications and core systems.
  • Study support task delegated to the Central Support Team within applicable scope.
• Ensures that internal/external customer expectations are achieved.
• Identifies best practices and participates in process improvement.
• Maintains compliance with departmental quality, performance, and utilization targets.
• Performs other work-related duties as assigned.

QUALIFICATION REQUIREMENTS

• Associate degree or equivalent combination of educations and training
• Administrative Experience.
• Good communication and interpersonal skills.
• Ability to interact effectively and appropriately cross multiple functional teams within the company.
• Ability to embrace new technologies.
• Demonstrate strong computer skills and proficiency in Microsoft Office Suite: (Outlook, Word, Excel, and PowerPoint).

• Ability to handle multiple tasks to meet deadlines in a dynamic environment with high level of accuracy, quality, and attention to detail.
• Ability to take direction from multiple individuals and set priorities accordingly.
• Strong organizational and time management skills.
• Must be able to work independently and in a team environment.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.

• Proficiency in the English language both written and verbal.
• Familiarity with electronic TMF system, minimal clinical or research experience preferred. 

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.

http://www.syneoshealth.com

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.