Job Description

Description

Clinical Operation Specialist (CTA I - Mumbai, Client office-based)
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.

Job Responsibilities

Must Have

+

Minimum 2- 3 Yrs of experience as CTA

+ Basic understanding of GCP, ICH Guidelines and local regulations as they apply.
+ Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
+ Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
+ Demonstrates ability to function independently
+ General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.
Preferred


+ Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
+ Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc...)
General Description


+ Manage the administrative and business activities related to the conduct of clinical trials (registrational and non- registrational /Investigator Sponsored Research Studies) with investigative sites from study start-up to study closure.
Key Responsibilities and Duties


+ Setting up vendors during study start up period (operational details from sites)
+ Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP)
+ Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Mytrials/Shared Investigator Portal) including conduct of completeness checks
+ Arranging drug and non-drug (Lab kits, ECG) importation to support study site
+ Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
+ Collect and distribute documents from / to sites during study life cycle
+ Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
+ Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
+ Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)
+ Obtain Insurance certificates
+ Preparing On Site Investigator File and other study related files
+ Support equipment calibration and tracking
+ Archiving process handling at study closure
+ May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.
+ May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)
+ May support Health Authority inspection and pre-inspection activities
+ May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

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 . 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.

Summary

Roles within Clinical Operations are responsible for ensuring safe and effective operations of clinical research studies. Responsible for safeguarding the wellbeing of research subjects in a medical capacity. Reviews study protocols, plans and executes procedures in alignment with protocols and regulatory, health, and safety standards, raising or escalating study issues. Recruits and coordinates communication with clinical trial volunteers and patients, and follows applicable regulations globally and by region. Collaborates with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study.Impact and ContributionIndividual contributors who provide organizational related support or service (administrative or clerical), as well as roles operating in support of daily business activities (e.g., technical, production, or craft levels). The majority of time is spent in the delivery of support services or activities, typically under supervision. Roles do not typically require advanced education or training. Established and experienced support individual contributor. Work consists of tasks that are typically routine, with some deviation from standard practice. Requires broad knowledge of operational systems and practices typically gained through extensive experience and/or education.