Clinical Trial Associate

0-5 years

Not Disclosed

Mumbai Vadodara

10 May 3, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Mumbai or Vadodara, 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 logistical 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
- Ensuring staff are aware of the most recent versions of QMS controlled documents
- Reviewing staff training records to ensure they are kept up to date
Ensuring learning and knowledge transfer during and at the completion of the trial(s)
Any other duties as required by the Head of Clinical Development and Chief Scientific Officer as well as assisting the wider Scientific Affairs organisation in activities other than those specified above
Some manual lifting is required within this job role e.g., moving files, archiving files, lifting boxes, carrying items from loading bay and around the office

About you:

Candidates who have previously worked as a Clinical Trial Associate and/or Document Manager in clinical research or pharmaceuticals are likely to have the skills required to be successful in this role. We are also looking for:

Bachelor’s degree in life sciences, pharmacy, health sciences, nursing or equivalent
Great IT skills including MS Office programs, and an aptitude for/interest in bringing in electronic systems
Previous experience within clinical research/trials and good knowledge of the whole trial process
Good understanding and experience of working to GCP guidelines
Knowledge, experience and implementation of eTMFs
Experience and knowledge of budgeting and tracking
Excellent professional communication skills, both written and verbal
Great interpersonal and interaction skills when dealing with internal and external clients/vendors and colleagues
Highly meticulous and methodical, detail oriented
Excellent time management and organisational skills with demonstrated ability to juggle multiple competing tasks, demands and deadlines
Able to work within a team as well as independently with minimal supervision
Positive attitude and a flexible, can-do approach to work

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

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