Ajay Sharma

A seasoned clinical research/healthcare professional with strong people management & project management experience and skills.

An overall extensive experience of more than 15 years which includes the managerial/leadership & project management experience of more than 8 years in clinical research domain including clinical data management (CDM), clinical operations (CTMS), pharmacovigilance/drug safety ( PhV), medical narrative writing, medical coding (MedDRA & WHO DD), Pharma Formulation and Development ( F&D ) , quality management, large team management, delivery of projects, internal & customer audits and direct global client & internal interactions.

Highest regard for integrity, code of ethics & confidentiality. A person with a very positive attitude, customer focus, attention to details and an ability to work in a matrix environment. I have been in managerial/leadership roles initiating, creating, developing mechanisms & systems for the smooth operational flow for customer/client satisfaction. Have been the initiator of a number of successful initiatives, quality control, performance management, conflict identification & resolution, resource allocation & management, employee engagement, recognition & rewards programs, creating capabilities & the required skill sets within teams, creating a business continuity strategy to ensure completion of all the activities & tasks of teams, process reengineering, attrition management & reducing initiatives and in the recruitment process (taking interviews & selecting the best talent towards various job roles). Managed & supervised various studies/projects (cdisc /sdtm), case processing (PhV),worked in the ‘startup, conduct & closeout stages’ of clinical data management, possesses good organizational skills, the ability to learn very quickly, excellent time management, meeting tight deadlines, managing multiple tasks, creating & strongly supporting various organizational initiatives with success. Have got very strong team development, interpersonal communication, presentation and computer skills like MS office.

Have been liaising in different audits till date, ensured the teams grew & contributed towards the profitability & added value to the overall business objectives of the business line (SBU) /Organization. Provided leadership to my teams (operational as well study related ) from time to time, gave a number of official mentoring programs & domain trainings to my teams and the groups that I had worked with and have been working (including soft skill trainings as well), have got hands on experience in Paper & Electronic data capture (EDC system) studies, eTMF and eClinical.

I was one of the three core management personnel’s, in terms of setting up, launching, establishing and growing Tata Consultancy Service’s first pharmacovigilance/drug operations in Mumbai and taking it to the next level in a years’ time. A core member of the first pharmacovigilance project (AERS) of Cognizant Technology Solutions in Mumbai, was involved in quality control, mentoring and supporting customer audits. Managed and successfully delivered more than 60 Projects in my career till date, have worked on the clinical studies (Phase 1 to Phase 4) for the top global pharmaceutical companies (EMA, USFDA & MHRA). Good knowledge of ICH GCP guidelines, good clinical data management practices (GCDMP), GVP, 21 CFR Part 11, CRF designing, audits, good manufacturing practice (WHO GMP), business process outsourcing (BPO) & life Sciences domain.

Databases Experience:

Medidata Rave, Phase Forward (Inform), Oracle Clinical, OC RDC, Data Labs, PheedIt, Argus, ARISg, RSGT , Right Track II , pTMF, ELARA & Advent.

Therapeutic Area Expertise:

Oncology, Cardiology, Neuropsychiatry, Infectious disease, Dermatology, Women’s health, Diabetology, Gastroenterology etc.

Education:

Bachelor of Pharmacy ‘B Pharma’, JSS College of Pharmacy (University Of Mysore)
Pursuing ‘Master of Business Administration’ (MBA) from IGNOU (completion expected in 2019)

Language Skills:

English, Hindi, Urdu, Punjabi, Tamil, Kannada, Kashmiri, Marathi and Dogri.