Clinical Research
Aktualisiert am 02.04.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.06.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Audit and inspection
Clinical Trial management
Clinical Trial Leader
Handling Audit and their CAPA
Project Management
Digital Trial Solutions
SOP Development
Strategic planning
Etatverwaltung
Functional oversight
CRO/Vendor management
CRO/Vendor Selection
Biosimilar Development
Digital technology in Clinical Trials
Qualitymanagement
Drug development
Cross functional team management
Phase I-IV Clinical Trials
Profit and loss account management
Analytical Thinking
Analytical thinking
Programmmanagement
Risk-Based Monitoring
English
Fluent
German
B1
Hindi
Fluent
Gujarati
Native

Einsatzorte

Einsatzorte

Munich (+300km) Germany (+500km)
Deutschland, Österreich
möglich

Projekte

Projekte

3 Jahre 2 Monate
2022-02 - heute

Phase 2 Clinical trial with and Without Ruxolitinib in Patients with Myelofibrosis

Associate Director - Clinical Trial Leader ICH GCP US FDA guidelines EMEA guideline ...
Associate Director - Clinical Trial Leader
  • Direct evidence generation for oncology trial, delivering database locks and readouts on time and within budget across over 50 global sites across the US & EU.
  • Lead global teams and manage CROs/vendors, optimizing quality and costs for multinational studies.
  • Achieved 100 percent recruitment for a Phase 2 oncology trial (300 patients, 6 arms) ahead of schedule in EU and USA.
  • Collaborate with R&D to integrate trials during sponsor transitions, ensuring seamless execution.
  • Design risk-based strategies, proactively mitigating issues to enhance trial success.
ICH GCP US FDA guidelines EMEA guideline GDPR CTMS eCRF MS office suit Risk management Study budget management Gantt preparation Audit and inspection
Munich Germany
2 Jahre 1 Monat
2020-01 - 2022-01

Clinical Research

Director
Director
  • Developed a digital platform for ethics committee management, improving efficiency for over 20 clients
  • Increased revenue by 200 percent through strategic oversight, sustaining profitability
  • Boosted client retention by 90 percent with innovative digital solutions
  • Implemented a branding strategy that elevated the social media with 80% growth in online engagement
  • Lead the initiative of Digitalization of the Ethics Committee via independent Clinical Research bodies like ISCR (Indian Society of Clinical Research)
auf Anfrage
Bangalore, India
6 Jahre 9 Monate
2013-05 - 2020-01

Operations- Biologics

Group Lead-Clinical
Group Lead-Clinical
  • Led biosimilar trials in oncology & rheumatology. 
  • Achieved 100 percent recruitment for a Phase 2 Rheumatology study (276 patients)
  • In a challenging oncology indication, the recruitment rate improved by 100% then maintained for 20+ months
  • For Phase3 rheumatology study, effectively negotiated and finalized CRO for US and EU delivery
  • Implemented risk-based monitoring tools, enhancing compliance and efficiency globally
Dr. Reddy's Laboratories Ltd.
Hyderabad, India
5 Jahre 8 Monate
2007-10 - 2013-05

Improving global trial delivery

Head of Clinical Operations, Sr PM & PM
Head of Clinical Operations, Sr PM & PM
  • Member of Business Leadership Team reporting to CEO, Integrated German and Thailand CRO operations, improving global trial delivery
  • Managed a team of over 40, accelerating project timelines by 10 percent with a matrix model
  • Won 8 major contracts from top pharma firms through outstanding execution
  • Contributed in the development of three drugs in Diabetes (Linagliptin), Lung Cancer ( Afatinib) and Idiopathic Pulmonary Fibrosis (Nintedanib ) 
  • Successfully managed US FDA inspection and multiple sponsor audits & CAPA.
Manipal AcuNova Ltd
Bangalore, India
4 Jahre 1 Monat
2003-10 - 2007-10

Associate & Associate Scientist- Discovery Research

Clinical Research
Clinical Research

Business unit focused on the development of New Chemical Entities in Oncology and Cardio-Diabetes indication

  • Monitored multiple Phase I (including First in Human) and Phase II Oncology & Cardio Metabolic studies with Pharmacokinetics samples
  • Managed in-house as well as in fully outsourced working model
  • Hands-on experience of overseeing Phase I & II studies in Fasting
  • Fed, Single and Multiple-dose escalation & Drug-Drug interactions in healthy volunteers

Lab
Hyderabad, India

Aus- und Weiterbildung

Aus- und Weiterbildung

2000 - 2002

Pharmacy (Pharmacology)

Master

L M College of Pharmacy, Ahmedabad, India


Position

Position

Kompetenzen

Kompetenzen

Top-Skills

Audit and inspection Clinical Trial management Clinical Trial Leader Handling Audit and their CAPA Project Management Digital Trial Solutions SOP Development Strategic planning Etatverwaltung Functional oversight CRO/Vendor management CRO/Vendor Selection Biosimilar Development Digital technology in Clinical Trials Qualitymanagement Drug development Cross functional team management Phase I-IV Clinical Trials Profit and loss account management Analytical Thinking Analytical thinking Programmmanagement Risk-Based Monitoring

Produkte / Standards / Erfahrungen / Methoden

Profile

Clinical Research Leader with over 22 years of experience in clinical trial management, evidence generation, and regulatory compliance across global pharma, biotech & CRO. Expert in leading cross-functional teams with functional domain. Managed Audit and inspections. Extensive knowledge of ICH-GCP, FDA guidelines. Ready to contribute a wealth of experience in handling SOP/processes.


KEY ACHIEVEMENTS

  • Achieved 100 percent on-time recruitment for a multiple clinical trials across Oncology, Rheumatology trials.
  • Published research in Indian Med Res (Sep 2021) on biosimilar pharmacokinetics and Perspectives in Clinical Research (Jul-Sep 2021) on COVID-19 trial impacts.
  • 200% revenue growth at start up while maintaining profitability through strategic leadership.
  • Secured 8 high-value projects from top global pharma sponsors via exceptional trial execution.
  • Launched a digital ethics committee platform, enhancing efficiency for over 20 clients.
  • Earned ?Best People Manager? award (2015) among 15,000 employees at Lab.


TECHNICAL SKILLS

Tools:

  • Clinical Trial Management Systems (CTMS) & MS Suite


Standards:

  • ICH Guidelines
  • GCP
  • GDPR
  • EMEA 
  • US FDA GUIDELINES


Methodologies:

  • Risk-Based Monitoring
  • Project Management
  • Digital Trial Solutions

Branchen

Branchen

Einsatzorte

Einsatzorte

Munich (+300km) Germany (+500km)
Deutschland, Österreich
möglich

Projekte

Projekte

3 Jahre 2 Monate
2022-02 - heute

Phase 2 Clinical trial with and Without Ruxolitinib in Patients with Myelofibrosis

Associate Director - Clinical Trial Leader ICH GCP US FDA guidelines EMEA guideline ...
Associate Director - Clinical Trial Leader
  • Direct evidence generation for oncology trial, delivering database locks and readouts on time and within budget across over 50 global sites across the US & EU.
  • Lead global teams and manage CROs/vendors, optimizing quality and costs for multinational studies.
  • Achieved 100 percent recruitment for a Phase 2 oncology trial (300 patients, 6 arms) ahead of schedule in EU and USA.
  • Collaborate with R&D to integrate trials during sponsor transitions, ensuring seamless execution.
  • Design risk-based strategies, proactively mitigating issues to enhance trial success.
ICH GCP US FDA guidelines EMEA guideline GDPR CTMS eCRF MS office suit Risk management Study budget management Gantt preparation Audit and inspection
Munich Germany
2 Jahre 1 Monat
2020-01 - 2022-01

Clinical Research

Director
Director
  • Developed a digital platform for ethics committee management, improving efficiency for over 20 clients
  • Increased revenue by 200 percent through strategic oversight, sustaining profitability
  • Boosted client retention by 90 percent with innovative digital solutions
  • Implemented a branding strategy that elevated the social media with 80% growth in online engagement
  • Lead the initiative of Digitalization of the Ethics Committee via independent Clinical Research bodies like ISCR (Indian Society of Clinical Research)
auf Anfrage
Bangalore, India
6 Jahre 9 Monate
2013-05 - 2020-01

Operations- Biologics

Group Lead-Clinical
Group Lead-Clinical
  • Led biosimilar trials in oncology & rheumatology. 
  • Achieved 100 percent recruitment for a Phase 2 Rheumatology study (276 patients)
  • In a challenging oncology indication, the recruitment rate improved by 100% then maintained for 20+ months
  • For Phase3 rheumatology study, effectively negotiated and finalized CRO for US and EU delivery
  • Implemented risk-based monitoring tools, enhancing compliance and efficiency globally
Dr. Reddy's Laboratories Ltd.
Hyderabad, India
5 Jahre 8 Monate
2007-10 - 2013-05

Improving global trial delivery

Head of Clinical Operations, Sr PM & PM
Head of Clinical Operations, Sr PM & PM
  • Member of Business Leadership Team reporting to CEO, Integrated German and Thailand CRO operations, improving global trial delivery
  • Managed a team of over 40, accelerating project timelines by 10 percent with a matrix model
  • Won 8 major contracts from top pharma firms through outstanding execution
  • Contributed in the development of three drugs in Diabetes (Linagliptin), Lung Cancer ( Afatinib) and Idiopathic Pulmonary Fibrosis (Nintedanib ) 
  • Successfully managed US FDA inspection and multiple sponsor audits & CAPA.
Manipal AcuNova Ltd
Bangalore, India
4 Jahre 1 Monat
2003-10 - 2007-10

Associate & Associate Scientist- Discovery Research

Clinical Research
Clinical Research

Business unit focused on the development of New Chemical Entities in Oncology and Cardio-Diabetes indication

  • Monitored multiple Phase I (including First in Human) and Phase II Oncology & Cardio Metabolic studies with Pharmacokinetics samples
  • Managed in-house as well as in fully outsourced working model
  • Hands-on experience of overseeing Phase I & II studies in Fasting
  • Fed, Single and Multiple-dose escalation & Drug-Drug interactions in healthy volunteers

Lab
Hyderabad, India

Aus- und Weiterbildung

Aus- und Weiterbildung

2000 - 2002

Pharmacy (Pharmacology)

Master

L M College of Pharmacy, Ahmedabad, India


Position

Position

Kompetenzen

Kompetenzen

Top-Skills

Audit and inspection Clinical Trial management Clinical Trial Leader Handling Audit and their CAPA Project Management Digital Trial Solutions SOP Development Strategic planning Etatverwaltung Functional oversight CRO/Vendor management CRO/Vendor Selection Biosimilar Development Digital technology in Clinical Trials Qualitymanagement Drug development Cross functional team management Phase I-IV Clinical Trials Profit and loss account management Analytical Thinking Analytical thinking Programmmanagement Risk-Based Monitoring

Produkte / Standards / Erfahrungen / Methoden

Profile

Clinical Research Leader with over 22 years of experience in clinical trial management, evidence generation, and regulatory compliance across global pharma, biotech & CRO. Expert in leading cross-functional teams with functional domain. Managed Audit and inspections. Extensive knowledge of ICH-GCP, FDA guidelines. Ready to contribute a wealth of experience in handling SOP/processes.


KEY ACHIEVEMENTS

  • Achieved 100 percent on-time recruitment for a multiple clinical trials across Oncology, Rheumatology trials.
  • Published research in Indian Med Res (Sep 2021) on biosimilar pharmacokinetics and Perspectives in Clinical Research (Jul-Sep 2021) on COVID-19 trial impacts.
  • 200% revenue growth at start up while maintaining profitability through strategic leadership.
  • Secured 8 high-value projects from top global pharma sponsors via exceptional trial execution.
  • Launched a digital ethics committee platform, enhancing efficiency for over 20 clients.
  • Earned ?Best People Manager? award (2015) among 15,000 employees at Lab.


TECHNICAL SKILLS

Tools:

  • Clinical Trial Management Systems (CTMS) & MS Suite


Standards:

  • ICH Guidelines
  • GCP
  • GDPR
  • EMEA 
  • US FDA GUIDELINES


Methodologies:

  • Risk-Based Monitoring
  • Project Management
  • Digital Trial Solutions

Branchen

Branchen

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