Shobha Manne
Associate Director Clinical Trials
Mainz
Summary
Hardworking Individual knowledgeable about business practices in the clinical research (Pharmaceutical or Biotech) industry. Adept at supporting and enhancing operations with a decisive leadership style and strategic approach to decision making.
Overview
16
16
years of professional experience
5
5
years of post-secondary education
4
4
Languages
Work History
Associate Director Clinical Trials
BioNTech SE
Mainz
7 2021 - Current
- Successfully leading pivotal Phase 1 oncology study targeting CLDN18-positive advanced solid tumors as Study Lead.
- Primary contact for clinical operations in collaborative studies, handling multiple collaboration studies in Phase 1 and early phases in oncology, responsible for study updates, recruitment status, and alignment with internal teams.
- Provide support for Phase I study evaluating safety and tolerability of investigational prophylactic vaccine for prevention of genital lesions caused by HSV (Herpes simplex virus).
- Contributed to study lead support on Phase I/II, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IMP as monotherapy and in combination with other anti-cancer agents in patients with solid tumors.
- Participated in development and feasibility process for Malaria and Tuberculosis program.
- Providing oversight for key regulatory documents and vendor interactions.
Mentored junior staff members, guiding professional development opportunities and career progression paths within company - Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within company
Clinical Project Manager
Novartis
Prague
04.2019 - 07.2021
- Led studies on RMS, Advanced breast cancer, and Acromegaly - Provided guidance on non-interventional studies - Managed trial teams, vendor interactions, audit preparations, and UAT testing
- Managed cross-functional teams, resulting in seamless collaboration and increased productivity in clinical projects
- Conducted thorough risk assessments for each project, proactively mitigating potential issues prior to escalations.
- Collaborated closely with medical experts, investigators, and external partners to ensure accurate data collection in line with research objectives
Clinical Project Manager
AB Science
Paris
06.2018 - 11.2018
- Managed Phase 3 studies for asthma, providing clinical expertise and leadership in project meetings.
- Oversaw communication with investigators and committees to ensure study success.
- Prepared reports, trial documents, and managed trial files to maintain organization and accuracy.
- Demonstrated strong project management skills to ensure timely and efficient completion of study milestones.
- Maintained high level of attention to detail to ensure compliance with regulatory requirements and guidelines.
- Collaborated with cross-functional teams to ensure successful study execution and delivery of high-quality results.
Senior Global Trial Manager
Novartis Health Care Pvt. Ltd
Hyderabad
09.2010 - 07.2018
- Led as Global Trial Manager on pivotal Phase III outcome-driven clinical mega-trial CANTOS, involving >10,000 patients in 39 countries.
- Managed Phase III extension study for obtaining further follow-up information on long-term safety on continued exposure to canakinumab in trial participants.
- Served as Global Trial Manager on Phase II adaptive seamless randomized, double-blind, placebo-controlled, dose-ranging study to investigate efficacy and safety of IMP in primary IgA nephropathy patients.
- Managed various aspects of study setup and execution, including timeline and milestone setup, document management system setup, trial feasibility discussions, trial master file and protocol package setup, audit and inspection readiness, and data review processes.
- Acted as primary contact for various vendors and was responsible for managing IRT-related deviations, data reviewing processes, and vendor follow-up.
Sr. Clinical Manager
Novartis Health Care Pvt. Ltd
Hyderabad
02.2016 - 06.2017
- Supported implementation and management of trial monitoring boards for CANTOS, successfully completing 3 DMCs.
- Coordinated with 10 countries for project-related activities.
- Assisted Global Trial Leader in ensuring all operational trial deliverables were met according to timelines, budget, procedures, and quality standards.
Sr. Clinical Research Specialist
Novartis Health Care Pvt. Ltd
Hyderabad
07.2013 - 01.2016
- Managed drug batch information and supply management - Verified trial documentation and maintained TMFs - Troubleshooted CTMR and CREDI systems
- Verified and coordinated with drug supply management at global level for re-supply needs for all study drugs at CPOs for trials without IVR tracking.
- Responsible for setting up and maintaining HQ Trial Master Files (TMF) and ensuring files were complete for each study center according to Novartis SOPs and guidelines.
- Ensured correct eCTD file naming convention for reference finalization in document management systems.
Clinical Supply Documentation Specialist
Novartis Health Care Pvt. Ltd
Hyderabad
09.2010 - 06.2013
- Established packaging documentation for Investigational Medicinal Products for clinical studies, according to GMP, GCP, and other regulations specific to country requirements.
- Managed vendors for external labeling, including grant approvals requests, raising purchase orders, and approval of invoices.
- Ensured compliance with study-specific and QA requirements.
Clinical Research Associate
Maya Clinicals CRO
Hyderabad
08.2009 - 08.2010
- Conducted monitoring visits, managed site documentation, and coordinated with sites and sponsors - Prepared feasibility studies and managed project proposals
- Set up and disbanded trial study centers to manage clinical study activities for 20 sites.
Study Coordinator
Kamineni Hospitals
Hyderabad
02.2008 - 08.2009
- Managed data collection, recruitment, regulatory submissions, and coordination of clinical trials - Responsible for drug storage, subject coordination, and communication with sponsors and laboratories
Education
Master of Science - Clinical Research
Institute of Clinical Research (India), Bangalore
Bangalore, India 09.2005 - 09.2007
Bachelor of Science - Biotechnology
St. Joseph's College, Bangalore
Bangalore, India 06.2002 - 06.2005
Certification Program - Basics in Pharmaceutical Medicine
Novartis Health Care Pvt Ltd.
Hyderabad, India 05.2016 - 10.2016
Skills
Clinical trial management
GCP Knowledge
Professional Highlights
- Contributed to the eTMF vendor selection process.
- Successfully negotiated eTMF access for Collaboration partners
- Played a pivotal role in training new clinical project managers and operation specialists.
- Received the Global Drug Development Star Award for ensuring high data quality in the CANTOS study.
- Published work on "Anti-inflammatory Therapy with Canakinumab for Atherosclerotic Disease" in NEJM, Lancet, and Science Daily
- Earned an Appreciation Award for developing Templates for Clinical Trial Team
- Recognized for substantial contributions to the Audit for the CANTOS study.
- Acknowledged for active development and key inputs for the CANTOS study Inspection.
- Awarded for extensive work on Patient Retention material for an Outcome study.
- Received Gold Above and Beyond recognition for significant work on an interim analysis involving 10,065 randomized patients.
- Awarded Gold Above and Beyond for Innovation at the 2016 Novartis Symposium
- Acknowledged for contribution and coordination of the DSM Carnival - A Knowledge Fair
- Nominated for the Global Experience Program in 2012
- Key user for Trackwise (AQWA)
Disclaimer
I hereby declare that the above stated information is true as per my knowledge.
Timeline
Clinical Project Manager
Novartis
04.2019 - 07.2021
Clinical Project Manager
AB Science
06.2018 - 11.2018
Certification Program - Basics in Pharmaceutical Medicine
Novartis Health Care Pvt Ltd.
05.2016 - 10.2016
Sr. Clinical Manager
Novartis Health Care Pvt. Ltd
02.2016 - 06.2017
Sr. Clinical Research Specialist
Novartis Health Care Pvt. Ltd
07.2013 - 01.2016
Senior Global Trial Manager
Novartis Health Care Pvt. Ltd
09.2010 - 07.2018
Clinical Supply Documentation Specialist
Novartis Health Care Pvt. Ltd
09.2010 - 06.2013
Clinical Research Associate
Maya Clinicals CRO
08.2009 - 08.2010
Study Coordinator
Kamineni Hospitals
02.2008 - 08.2009
Master of Science - Clinical Research
Institute of Clinical Research (India), Bangalore
09.2005 - 09.2007
Bachelor of Science - Biotechnology
St. Joseph's College, Bangalore
06.2002 - 06.2005
Associate Director Clinical Trials
BioNTech SE
7 2021 - Current
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