Clinical Trial Associate

2 weeks ago

Vadodara Gujarat, India Ortolan Group Full time

**Clinical Trial Associate**

Vadodara or Mumbai, India (hybrid: 3 days office, 2 days home)

**Salary**: Competitive + Benefits + Bonus

If you are an agile, committed, and innovative clinical trial professional then we want to hear from you

Join us to help improve peoples' lives and make healthcare better for everyone

***

**Why Pharmanovia?**

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands and our people.
- We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

**About the role**:
***

As Clinical Trial Associate you will support the Clinical Trial Manager and Real-World Evidence Trial Manager in the effective documentation and coordination of logístical aspects of assigned trials, and act as a pivotal point of contact and support for the trial team.

Reporting to the Head of Clinical Development, you will take a leading role in the creation and maintenance of study documents. In addition this is an important role in supporting the development and maintenance of the Clinical Quality Management System ensuring SOPs, policies, manuals and staff training records are kept complete and up-to-date, and that the QMS reflects current and best practice.

Our Clinical Development Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

**Main responsibilities & duties**:

- Responsibility for ensuring that the Sponsor Oversight File (SOF) and/or the Trial Master File (TMF), to include electronic TMFs, is complete and accurate on an ongoing basis and ready for archiving according to timelines
- Performing/overseeing periodic QC of SOFs and/or TMFs at Pharmanovia to ensure completeness and accuracy
- Performing QC of any TMF maintained by Service Providers (SPs) during and at the end of a study as well as an evaluation of the SPs TMF processes before study initiation
- Maintaining and updating any electronic study folders to ensure eFiles reflect any paper TMF/SOF and vice versa
- Support with clinical archiving to ensure timely coordination of archiving study documentation.
- Arranging and participating in the organisation of Investigator Meetings & Study Team Meetings (internal and external), preparing agendas and taking (where appropriate) and distributing minutes as required
- Coordinating any study document reviews where required
- Assisting with the Ethics submissions; keep a track of submissions & approvals for the study. Liaise with Regulatory Affairs to ensure linkage with regulatory approvals
- Printing, distributing and tracking of any study specific documents internally and to any SPs
- Creating and maintaining study contact lists and relevant information databases for study team
- Sending out Study Newsletters / Study Correspondence to all participating SPs/sites on an ongoing basis
- Facilitating and tracking any study payments following the internal approval process
- Facilitating the obtaining and maintenance of study insurances
- Conduct oneself at all times in accordance with Pharmanovia Quality Management System, company working practices and policies, applicable GxP regulations ensuring training in these areas is kept up-to-date at all times
- Assisting with the company's Clinical Quality Management System:

- Reviewing, updating and expanding Standard Operating Procedures and associated documents, policies, and manuals
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