Nishi Sharma Upadhayay

Associate Partner

Mumbai, Maharashtra, India19 yrs 1 mo experience

Highly Stable

Key Highlights

19+ years of experience in clinical data management.
Expert in regulatory compliance for clinical digital applications.
Proficient in data protection assessment frameworks.

Stackforce AI infers this person is a Healthcare Compliance and Data Management Expert.

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Skills

Core Skills

Computer System ValidationProject ManagementClinical Data Management

Other Skills

Project Team ManagementSystem ImplementationsData ManagementRegulatory ComplianceExterro ECACollection and ProcessingPeople ManagementData Privacy TrainingData Protection ActClinevo OneQMSTeam ManagementPharmaceutical IndustryBudget ManagementCRO ManagementContract Negotiation

About

Expertise and strong base in Implementing, validating and auditing Clinical Digital applications as per 21 CFR part 11 Compliance, EU Annex 11. Proficient in developing and validating data protection assessment framework as per Global Data Protection laws in healthcare industry. Expertise in performing internal and external study audit to ensure QMS processes. 19+ years Profound experience in overseeing and supervision of Data management processes. Lead and participate in UAT and ensure data integrity for clinical data. In-depth Experience in developing SOPs for Clinical Data Management. Driven independently the development and validation of computer systems based on medical devices in accordance with ISO, IEC standards.

Experience

Alpha md

Associate Vice President

Oct 2022 – Present · 3 yrs 6 mos · Mumbai, Maharashtra, India

Cipla

6 roles

Function lead - Clinical technology

Dec 2018 – Dec 2021 · 3 yrs

Project Manager- Clinical Technology

Jun 2015 – Dec 2018 · 3 yrs 6 mos

1.Responsible for implementation of Computer system validation for data management systems and medical devices in Clinical Research Departments. Develop and review Change control, User requirement specification, Requirement traceability matrix, test scripts and protocols. Perform and supervise IQ, OQ PQ testing .
2. Identify process gaps and propose cost effective IT solutions considering industry best practices.Responsible for end to end development and implementation of software solutions.
3.Ensure clinical data management processes for all clinical trials comply with regulatory requirement and industry standards.
4.Responsible for upgradation of all clinical data standards by bringing latest technology base and training the team with industry best practices.
5. Primarily responsible for coordinating with vendors and IT team for automating clinical trial processes.

Project Manager

Mar 2007 – Oct 2022 · 15 yrs 7 mos

Computer System ValidationProject Team ManagementClinical Data ManagementSystem ImplementationsProject Management

Clinical Data Manager

Mar 2007 – Oct 2022 · 15 yrs 7 mos

Project Lead

Promoted

Mar 2007 – Sep 2022 · 15 yrs 6 mos

Data Manager

Mar 2007 – Jun 2015 · 8 yrs 3 mos

1) Review of Clinical Data management documents
a) Case report Form,
b) Data Management Plan,
c) Data validation plan.
d) Raw Data listings
2. Manage Program management office by ensuring development and maintenance of various databases eg. Consultants, templates, agreements, project status, CROs, lessons learnt, issue logs in order to achieve centralization in processes across programs/projects.
3. Ensure that the Program/Project Team will collect, organize, store, and manage project documents in a central repository. This includes maintaining current and archival files (electronic and paper), collecting and distributing information to and from stakeholders, and entering updates into internal weekly status reports and project tracking systems.
4. Managing study medication department activities by periodic reviews to ensure timely availability of samples and timelines are met as per project plan.
5. Assess training and support needs for program lead through regular monthly reviews in order to meet program goals.
6. Develop clinical data standards across clinical programs to comply with regulatory requirement and industry standards.