Anushka Vishal
Bangalore
Summary
Experienced professional and leader skilled in driving strategic initiatives and fostering effective team collaboration. Proven track record in project management, budget oversight, and stakeholder engagement, ensuring efficient achievement of organizational goals. Recognized for adaptability, reliability, and a strong focus on delivering impactful results. Skilled in leveraging data-driven insights, optimizing processes, and mentoring teams to excel in dynamic environments.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Associate Director
Navitas Life Sciences
11.2022 - Current
- Spearheaded cross-departmental initiatives to streamline clinical trial processes, resulting in a 25% reduction in cycle times
- Led a team of 10+ to coordinate study startup, regulatory documentation, and site activation across India and the broader APAC region
- Ensured adherence to ICH-GCP, FDA, and EMA guidelines, minimizing compliance risk and audit findings
- Partnered with stakeholders in data management, biostatistics, and medical affairs to align clinical strategies
- Built and maintained strategic client relationships by aligning project delivery with client expectations and proactively resolving escalations
- Provided executive leadership in cross-functional planning, contributing to operational strategy development and key account growth initiatives
Global Study Delivery Lead
GSK
10.2020 - 11.2022
- Managed and led over 5 pivotal global Phase II and III clinical trials, including vaccine studies, across oncology and rare diseases
- Achieved milestones such as FPI, database lock, and regulatory submissions within target timelines
- Managed vendors, budgets ($5M+), and performance KPIs
- Introduced integrated operational planning, improving timeline adherence by 30%
Trip Report Reviewer II
Covance
02.2019 - 10.2020
- Reviewed monitoring visit trip reports for multiple studies across therapeutic portfolios, acting as the single point of contact for global project management teams
- Modeled and analyzed study dashboard metrics using key risk indicators (KRIs) to identify trends and ensure proactive oversight
- Recognized for leading key process initiatives that enhanced documentation quality and turnaround time
- Mentored junior colleagues to streamline learning processes and improve report review efficiency
- Collaborated cross-functionally with global stakeholders to resolve discrepancies and support audit readiness
Visit Report Approver
ICON Plc
05.2015 - 02.2019
- Reviewed visit reports across diverse therapeutic areas including endocrinology, oncology, nephrology, respiratory, dermatology, gene therapy, and pediatric vaccines
- Acted as lead Visit Report Approver (VRA) for high-volume, complex global projects involving multiple VRAs, ensuring high-quality and timely documentation
- Liaised with internal and external stakeholders globally to ensure timely delivery of Phase II, III, and IV projects
- Provided mentorship and backup support to junior VRAs, contributing to team cohesion and development
- Played a key role in departmental initiatives including SOP revisions and quality improvement plans, supporting operational excellence
Clinical Project Leader
AstraZeneca
08.2013 - 05.2015
- Managed and led a Phase IV asthma trial (14 sites, 700 patients) and a Phase III anemia trial in CKD dialysis patients (12 sites, 100 patients)
- Monitored multiple Phase III studies including nosocomial pneumonia (10 sites, 100 patients), cardiovascular outcomes in Type 2 Diabetes (16 sites, 200 patients), and a Phase IIIb diabetes trial (12 sites, 200 patients)
- Oversaw overall project delivery, ensuring quality, compliance, budget control, and timeline adherence
- Collaborated with global teams on costing, contract development, and operational strategy for clinical trials
- Coordinated with regulatory teams for the preparation and submission of clinical trial documentation, including SEC and Technical Committee materials
- Achieved key performance milestones including 50% patient recruitment ahead of plan and zero critical audit findings
- Delivered data sweep timelines ahead of schedule and ensured seamless CRA transitions at trial sites
- Mentored new team members and led multiple high-performing project teams simultaneously, driving successful recruitment and operational execution
Local Study Team Leader
AstraZeneca
02.2011 - 07.2013
- Managed and led a Phase II gastric carcinoma study (7 sites, 140 patients), overseeing protocol implementation, site operations, and patient safety
- Oversaw full delivery of a Phase III infection trial (16 sites, 800 patients), ensuring timely recruitment, regulatory compliance, and data integrity
- Led project operations for a Phase III cardiovascular trial evaluating prevention of thrombotic events, collaborating with investigators and vendors across all trial phases
- Delivered key milestones such as FPI, LPO, and database lock on schedule, while maintaining high data quality and compliance across sites
- Provided end-to-end project leadership across quality, scope, timelines, resources, finances, and risk mitigation
- Collaborated with internal departments for resource planning, site contracting, budgeting, and vendor management to align operational delivery with corporate strategy
- Supported regulatory submission packages and provided guidance during regulatory interactions
- Mentored study teams of 3–6 professionals, creating a high-performance culture and facilitating knowledge transfer
- Conducted comprehensive feasibility assessments and therapeutic area research to inform protocol design and optimize site selection
Quality Control Associate & Trainer
Clinigene Pvt Ltd
05.2008 - 02.2011
- Conducted audits and quality checks across over 120 clinical sites in therapeutic areas including diabetes, oncology, rheumatology, and cardiology to ensure protocol compliance and data accuracy
- Led initiatives for the drafting, review, and implementation of standard operating procedures (SOPs) as an active member of the SOP Review Committee
- Designed and delivered training programs for new hires, successfully onboarding 14 Clinical Research Associates (CRAs) and 3 Clinical Trial Assistants (CTAs)
- Facilitated cross-functional knowledge transfer sessions to enhance team readiness for monitoring and quality assurance activities
- Generated detailed quality audit reports, analyzed recurring issues, and provided strategic recommendations to senior management for continuous improvement
- Played a key role in shaping internal quality frameworks and training protocols for CRA teams
- Contributed to organizational inspection readiness by improving SOP clarity and audit documentation practices
- Recognized for driving consistency in quality reviews and mentoring junior quality staff
- Successfully audited over 120 clinical sites across various therapeutic areas
- Recognized for training excellence and induction of 14 CRAs and 3 CTAs
- Actively contributed to drafting and refining operational SOPs
Clinical Research Associate
Clinigene Pvt Ltd
08.2007 - 05.2008
- Monitored over 20 investigational sites to ensure data integrity, protocol adherence, and patient safety across various phases of clinical trials
- Conducted site qualification, initiation, monitoring, and close-out visits in compliance with GCP guidelines
- Supported protocol development, feasibility assessments, and CRF design through collaboration with cross-functional teams
- Authored comprehensive monitoring visit reports and collaborated with QA teams to ensure audit readiness and resolve quality issues
- Maintained effective site communication and coordinated resolution of site-level issues, supporting successful study delivery
Education
Senior Management Programme -
Indian Institute of Management Calcutta
12.2022
Master of Science - Biotechnology
Bangalore University
12.2006
Bachelor of Science -
Bangalore University
12.2004
Skills
- Clinical Trial Management (Phase I–IV)
- Global Strategy
- Resource Optimization
- Business Planning
- Regulatory Compliance (ICH-GCP, FDA, EMA)
- Process Optimization & SOP Development
- Cross-functional Team Leadership
- Risk-Based Monitoring (RBM)
- Vendor & Stakeholder Management
- Budgeting & Forecasting
- GxP Audits & Inspections
- CTMS
- ETMF
- EDC Systems (eg, Medidata, Veeva Vault)
Certification
- Certified Clinical Research Professional (CCRP), Clinigene Pvt Ltd, 01/01/07
- Six Sigma Green Belt, Not Provided, 01/01/04
- SMP Certification, IIMC, 01/01/22
Languages
English
Hindi
Kannada
Tamil
Timeline
Associate Director
Navitas Life Sciences
11.2022 - Current
Global Study Delivery Lead
GSK
10.2020 - 11.2022
Trip Report Reviewer II
Covance
02.2019 - 10.2020
Visit Report Approver
ICON Plc
05.2015 - 02.2019
Clinical Project Leader
AstraZeneca
08.2013 - 05.2015
Local Study Team Leader
AstraZeneca
02.2011 - 07.2013
Quality Control Associate & Trainer
Clinigene Pvt Ltd
05.2008 - 02.2011
Clinical Research Associate
Clinigene Pvt Ltd
08.2007 - 05.2008
Master of Science - Biotechnology
Bangalore University
Bachelor of Science -
Bangalore University
Senior Management Programme -
Indian Institute of Management Calcutta
Similar Profiles
Likitha AdigopulaLikitha Adigopula
Drug Safety Associate II at Navitas life sciencesDrug Safety Associate II at Navitas life sciences
Nrusingha Charan BeheraNrusingha Charan Behera
AGM-Legal and Compliance at TAKE Solutions Ltd. (Navitas Life Sciences)AGM-Legal and Compliance at TAKE Solutions Ltd. (Navitas Life Sciences)
Zuleikha FathimaZuleikha Fathima
Junior Regulatory Associate at Navitas Life Sciences Pvt LtdJunior Regulatory Associate at Navitas Life Sciences Pvt Ltd