Cta (Mumbai Location)

2 weeks ago

India Syneos Health Clinical Full time

**Description**

**CTA (Mumbai Location)**

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 SUMMARY**:
**JOB RESPONSIBILITIES**
- Responsible for performing activities in compliance with applicable Corporate and Clinical Operations
- Policies, Standard Operating Procedures and Work Instructions
- Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities, as applicable.
- Sets up systems.
- Supports vendor selection, TPRM process, SIM entries.
- SMF and TMF management (country and site TMF); set-up and maintenance according to regulatory and requirements; document oversight and tracking
- Supports vendor set-up as applicable.
- Checks site “Green Light” completeness and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Supports preparation and translation of ICF to local languages (including vendor management, if necessary)
- Supports preparation of patient facing material
- Responsible for completeness of uploaded trial-related documents into eTMF, including archiving of paper TMFs.
- Supports country SSU strategy in close collaboration with the SSU Team Lead and SSU Managers to ensure SSU timelines and deliverables are met according to country commitments.
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Provides logistic support to SSU CRA, CRA, CPM, SSU Manager during all phases of the clinical trial.
- Implements innovative and efficient processes which are aligned with organizational strategy
- Provide logistics support to SSU CRA CPM and SSU manager in all phases of clinical trial
- Participates in file audits
- Prepares and maintains site manuals, reference tools and other documents
- Maintains, updates, and inputs clinical tracking information into databases
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
- Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
- Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
- May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

**Qualifications**

**What we’re looking for**
- Any life science Graduate.
- **Minimum 2 years of experience in relevant field.**:

- Strong process understanding
- Demonstrated collaboration and communication skills.
- Good knowledge of ICH/GCP and prevailing regulations, preferred
- Ability to successfully prioritize and work on multiple tasks
- Strong attention to detail, accuracy and organizational skills
- Excellent communication, presentation, and interpersonal skills
- Ability to embrace new technologies.

**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 P

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