Clinical Research
Aktualisiert am 03.12.2025
Profil
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Remote-Arbeit
Verfügbar ab: 08.12.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Global Clinical Trial management
Audit and inspection management
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 Full Professional Proficiency
German
B1
Hindi
Fluent Full Professional Proficiency
Gujarati
Native Native or Bilingual Proficiency

Einsatzorte

Einsatzorte

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

Projekte

Projekte

3 Jahre 4 Monate
2022-02 - 2025-05

Global Clinical Trial Leader of a complex Phase 2 oncology study

Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology US FDA guidelines EMEA guideline GDPR ...
Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology

  • Directed global clinical operations strategy for large complex Phase II oncology trial (N=300 patients) with imaging endpoints across EU & U.S. sites, delivered milestones aligned with corporate objectives and regulatory timelines
  • Managed Vendor relationships with CROs and 11 vendors, leading contract negotiations, performance reviews, and escalation management
  • Held full accountability for a $70M+ cumulative study budget, integrating forecasts into corporate planning
  • Embedded CAPA-driven compliance culture sites, countries, and vendors leading to inspection readiness and project performance
  • Partnered with the Medical Director and cross-functional leaders to align operational strategy with the Clinical Development Plan

US FDA guidelines EMEA guideline GDPR eCRF Risk management Study budget management Gantt preparation Audit and inspection Strategic Clinical Operations Leadership ICH GCP MS office suit Cross-functional collaboration in matrix environments Conflict resolution Driving a patient-centric culture Decision making Vendor and CRO management Inspection readiness Issue escalation and resolution Qualitymanagement
Morphosys GmbH (A Novartis company)
Munich Germany
2 Jahre 1 Monat
2020-01 - 2022-01

Director Clinical Research at bootstrapped pharma digital Start up

Director- Clinical Research Digital Start up Computerized System Validation Business Development ...
Director- Clinical Research
  1. Launched a Digital ethics committee platform as a SaaS, cutting document turnaround time and improving regulatory compliance for 20+ clients
  2. Established and led clinical strategy in a start-up setting, building CRO/Sponsor partnerships and securing high-impact pharma collaborations
  3. Directed Profit and Loss, achieving 100% revenue growth and 90% client retention through operational excellence
  4. Lead the initiative of Digitalization of the Ethics Committee via independent Clinical Research bodies like ISCR (Indian Society of Clinical Research)
Software as a Service
Digital Start up Computerized System Validation Business Development Good Automated Manufacturing Practice Software as a Service Performance Qualification Kundenbetreuung Operational Qualification Installation Qualification social media management training management Team management Performance-Management
Sponsor and CRO including Sites & Ethics Committees
Bangalore, India
6 Jahre 9 Monate
2013-05 - 2020-01

Global Clinical Operations- Biologics

Group Lead- Global Clinical Operations- Biologics Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) ...
Group Lead- Global Clinical Operations- Biologics
  • Led Global clinical operations for the biologics program (Rituximab), including Phase III immunology and oncology trials. This drug is approved by EMA in SEP 2024
  • Directed global CRO governance and vendor oversight across EU and Asia, embedding risk-based monitoring and proactive issue resolution
  • Served as Escalation lead for trial quality issues, strengthening compliance and audit readiness
  • Recognized with "Best People Manager" award among 15,000 employees for leadership and team development
  • Line management to clinical operations teams, fostering capability building and succession planning
Rituximab Trastuzumab Peg Grafeel
Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) Vendor and CRO management Project Management Programmmanagement Etatverwaltung Risikomanagement Inspection Readiness Process improvement and optimization Issue escalation and resolution Conflict resolution Cross-functional collaboration in matrix environments real world evidence study Risk based monitoring
Dr. Reddy's Laboratories Ltd.
Hyderabad, India
5 Jahre 8 Monate
2007-10 - 2013-05

Trial Delivery from CRO to all types of pharma sponsors.

Head of Clinical Operations, Sr PM & PM Kundenbetreuung Profit and Loss Customer escalation management ...
Head of Clinical Operations, Sr PM & PM
  • Directed clinical operations and Drug supply teams of 40+ (Leads and PMs) with full P&L responsibility, consistently meeting financial targets
  • Served as primary point of escalation for CRO/vendor performance issues, driving resolution to safeguard study timelines, budget, and compliance
  • Negotiated and secured 8 global pharma contracts, positioning the company as their a trusted partner in Oncology, and Diabetes.
  • Direct oversight of Phase II & III trials towards to the development of three drugs' approval: Linagliptin (diabetes), Afatinib (lung cancer), Nintedanib (IPF)
  • Oversaw US FDA inspection, including successful US FDA of Neurology project resulting drug's approval.
Kundenbetreuung Profit and Loss Customer escalation management Line management Kollaboratives Projektmanagement Project delivery Delivery expansion Performance-Management Coaching Talentmanagement
Navitas LifeScience
Bangalore, India
4 Jahre 1 Monat
2003-10 - 2007-10

First in Human studies Monitoring in Oncology and Cardiodiabetes

Clinical Research Associate - Discovery Research site monitoring First in human study Protocol review ...
Clinical Research Associate - Discovery Research

I worked in the business unit focused on the development of New Chemical Entities in Oncology and Cardio-Diabetes

  • Monitored multiple Phase I (including First in Human) and Phase II Oncology & Cardio Metabolic studies with Pharmacokinetics samples logistics management in in-house as well as Fully outsourced model.
  • Developed foundational expertise in clinical trial conduct and quality oversight

DRL-1042 DRF 1644 DRL 10945 RUS 3108
site monitoring First in human study Protocol review On site monitoring Sponsor co-monitoring
Dr. Reddy's Lab
Hyderabad, India

Aus- und Weiterbildung

Aus- und Weiterbildung

2000 - 2002

Pharmacy (Pharmacology)
Master
L M College of Pharmacy, Ahmedabad, India

Position

Position

  • Global Clinical Operations Leader
  • Phase II Oncology & Imaging Trials
  • CRO Governance
  • Budget & Regulatory Accountability

Kompetenzen

Kompetenzen

Top-Skills

Global Clinical Trial management Audit and inspection management 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

Project management
Experte
Clinical Trial management
Fortgeschritten

Profiles:

Over 20 years of global clinical operations expertise applied to Phase II-III oncology trials with imaging endpoints. Skilled in CRO governance, budget accountability, and regulatory compliance, with a record of resolving escalations, safeguarding timelines, and ensuring inspection readiness while aligning trial delivery with strategic development objectives


KEY ACHIEVEMENTS:

  • Directed global Phase II oncology trial with imaging endpoints, ensuring delivery of on-time recruitment, database locks, & CSR delivery across EU, and U.S. sites in a full outsourced model
  • Served as the primary point of escalation for CRO/vendor performance for timely issue resolution within governance frameworks
  • Supported EMA approval of Oncology-Immunology drug & successful US FDA inspection by ensuring operational rigor under regulatory scrutiny
  • Held full accountability for $70M+ cumulative trial budget, integrating forecasts into corporate planning. 
  • Built and managed high-performing clinical operations teams (40+ staff), embedding CAPA culture & inspection readiness
  • Recognized with "Best People Manager" award among 15,000 employees for leadership and team development


Tools:

  • Clinical Trial Management Systems (CTMS)
  • Microsoft Project & MS Suite
  • Veeva RIMs
  • Veeva Quality


Standards:

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


Methodologies:

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


Leadership:

  • Strategic Clinical Operations Leadership
  • Stakeholder Engagement
  • Cross-Functional Leadership
  • Executive Communication
  • Multicultural Collaboration
  • Change Management & Sponsor Transition Integration
  • Line Management
  • Talent Development


Competence:

  • Phase II and Phase III Clinical Trial Management (Oncology)
  • CRO & Vendor Governance
  • Budget Management
  • Risk-Based Monitoring
  • Escalation Management
  • Operational Excellence
  • Inspection Readiness
  • Governance frameworks
  • Change Management
  • Financial oversight
  • Innovation Mindset
  • SOP development

Klinische Forschung

Project management
Experte
Strategic Global Clinical Operation
Fortgeschritten
Budget management
Experte
Risk management
Experte
Vendor and CRO management
Experte
Patient recruitment and retention strategies
Fortgeschritten
Inspection Readiness
Fortgeschritten
Governance frameworks
Fortgeschritten
Change Management
Fortgeschritten
Operational Excellence
Fortgeschritten
Escalation Management
Fortgeschritten

Branchen

Branchen

Einsatzorte

Einsatzorte

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

Projekte

Projekte

3 Jahre 4 Monate
2022-02 - 2025-05

Global Clinical Trial Leader of a complex Phase 2 oncology study

Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology US FDA guidelines EMEA guideline GDPR ...
Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology

  • Directed global clinical operations strategy for large complex Phase II oncology trial (N=300 patients) with imaging endpoints across EU & U.S. sites, delivered milestones aligned with corporate objectives and regulatory timelines
  • Managed Vendor relationships with CROs and 11 vendors, leading contract negotiations, performance reviews, and escalation management
  • Held full accountability for a $70M+ cumulative study budget, integrating forecasts into corporate planning
  • Embedded CAPA-driven compliance culture sites, countries, and vendors leading to inspection readiness and project performance
  • Partnered with the Medical Director and cross-functional leaders to align operational strategy with the Clinical Development Plan

US FDA guidelines EMEA guideline GDPR eCRF Risk management Study budget management Gantt preparation Audit and inspection Strategic Clinical Operations Leadership ICH GCP MS office suit Cross-functional collaboration in matrix environments Conflict resolution Driving a patient-centric culture Decision making Vendor and CRO management Inspection readiness Issue escalation and resolution Qualitymanagement
Morphosys GmbH (A Novartis company)
Munich Germany
2 Jahre 1 Monat
2020-01 - 2022-01

Director Clinical Research at bootstrapped pharma digital Start up

Director- Clinical Research Digital Start up Computerized System Validation Business Development ...
Director- Clinical Research
  1. Launched a Digital ethics committee platform as a SaaS, cutting document turnaround time and improving regulatory compliance for 20+ clients
  2. Established and led clinical strategy in a start-up setting, building CRO/Sponsor partnerships and securing high-impact pharma collaborations
  3. Directed Profit and Loss, achieving 100% revenue growth and 90% client retention through operational excellence
  4. Lead the initiative of Digitalization of the Ethics Committee via independent Clinical Research bodies like ISCR (Indian Society of Clinical Research)
Software as a Service
Digital Start up Computerized System Validation Business Development Good Automated Manufacturing Practice Software as a Service Performance Qualification Kundenbetreuung Operational Qualification Installation Qualification social media management training management Team management Performance-Management
Sponsor and CRO including Sites & Ethics Committees
Bangalore, India
6 Jahre 9 Monate
2013-05 - 2020-01

Global Clinical Operations- Biologics

Group Lead- Global Clinical Operations- Biologics Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) ...
Group Lead- Global Clinical Operations- Biologics
  • Led Global clinical operations for the biologics program (Rituximab), including Phase III immunology and oncology trials. This drug is approved by EMA in SEP 2024
  • Directed global CRO governance and vendor oversight across EU and Asia, embedding risk-based monitoring and proactive issue resolution
  • Served as Escalation lead for trial quality issues, strengthening compliance and audit readiness
  • Recognized with "Best People Manager" award among 15,000 employees for leadership and team development
  • Line management to clinical operations teams, fostering capability building and succession planning
Rituximab Trastuzumab Peg Grafeel
Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) Vendor and CRO management Project Management Programmmanagement Etatverwaltung Risikomanagement Inspection Readiness Process improvement and optimization Issue escalation and resolution Conflict resolution Cross-functional collaboration in matrix environments real world evidence study Risk based monitoring
Dr. Reddy's Laboratories Ltd.
Hyderabad, India
5 Jahre 8 Monate
2007-10 - 2013-05

Trial Delivery from CRO to all types of pharma sponsors.

Head of Clinical Operations, Sr PM & PM Kundenbetreuung Profit and Loss Customer escalation management ...
Head of Clinical Operations, Sr PM & PM
  • Directed clinical operations and Drug supply teams of 40+ (Leads and PMs) with full P&L responsibility, consistently meeting financial targets
  • Served as primary point of escalation for CRO/vendor performance issues, driving resolution to safeguard study timelines, budget, and compliance
  • Negotiated and secured 8 global pharma contracts, positioning the company as their a trusted partner in Oncology, and Diabetes.
  • Direct oversight of Phase II & III trials towards to the development of three drugs' approval: Linagliptin (diabetes), Afatinib (lung cancer), Nintedanib (IPF)
  • Oversaw US FDA inspection, including successful US FDA of Neurology project resulting drug's approval.
Kundenbetreuung Profit and Loss Customer escalation management Line management Kollaboratives Projektmanagement Project delivery Delivery expansion Performance-Management Coaching Talentmanagement
Navitas LifeScience
Bangalore, India
4 Jahre 1 Monat
2003-10 - 2007-10

First in Human studies Monitoring in Oncology and Cardiodiabetes

Clinical Research Associate - Discovery Research site monitoring First in human study Protocol review ...
Clinical Research Associate - Discovery Research

I worked in the business unit focused on the development of New Chemical Entities in Oncology and Cardio-Diabetes

  • Monitored multiple Phase I (including First in Human) and Phase II Oncology & Cardio Metabolic studies with Pharmacokinetics samples logistics management in in-house as well as Fully outsourced model.
  • Developed foundational expertise in clinical trial conduct and quality oversight

DRL-1042 DRF 1644 DRL 10945 RUS 3108
site monitoring First in human study Protocol review On site monitoring Sponsor co-monitoring
Dr. Reddy's Lab
Hyderabad, India

Aus- und Weiterbildung

Aus- und Weiterbildung

2000 - 2002

Pharmacy (Pharmacology)
Master
L M College of Pharmacy, Ahmedabad, India

Position

Position

  • Global Clinical Operations Leader
  • Phase II Oncology & Imaging Trials
  • CRO Governance
  • Budget & Regulatory Accountability

Kompetenzen

Kompetenzen

Top-Skills

Global Clinical Trial management Audit and inspection management 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

Project management
Experte
Clinical Trial management
Fortgeschritten

Profiles:

Over 20 years of global clinical operations expertise applied to Phase II-III oncology trials with imaging endpoints. Skilled in CRO governance, budget accountability, and regulatory compliance, with a record of resolving escalations, safeguarding timelines, and ensuring inspection readiness while aligning trial delivery with strategic development objectives


KEY ACHIEVEMENTS:

  • Directed global Phase II oncology trial with imaging endpoints, ensuring delivery of on-time recruitment, database locks, & CSR delivery across EU, and U.S. sites in a full outsourced model
  • Served as the primary point of escalation for CRO/vendor performance for timely issue resolution within governance frameworks
  • Supported EMA approval of Oncology-Immunology drug & successful US FDA inspection by ensuring operational rigor under regulatory scrutiny
  • Held full accountability for $70M+ cumulative trial budget, integrating forecasts into corporate planning. 
  • Built and managed high-performing clinical operations teams (40+ staff), embedding CAPA culture & inspection readiness
  • Recognized with "Best People Manager" award among 15,000 employees for leadership and team development


Tools:

  • Clinical Trial Management Systems (CTMS)
  • Microsoft Project & MS Suite
  • Veeva RIMs
  • Veeva Quality


Standards:

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


Methodologies:

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


Leadership:

  • Strategic Clinical Operations Leadership
  • Stakeholder Engagement
  • Cross-Functional Leadership
  • Executive Communication
  • Multicultural Collaboration
  • Change Management & Sponsor Transition Integration
  • Line Management
  • Talent Development


Competence:

  • Phase II and Phase III Clinical Trial Management (Oncology)
  • CRO & Vendor Governance
  • Budget Management
  • Risk-Based Monitoring
  • Escalation Management
  • Operational Excellence
  • Inspection Readiness
  • Governance frameworks
  • Change Management
  • Financial oversight
  • Innovation Mindset
  • SOP development

Klinische Forschung

Project management
Experte
Strategic Global Clinical Operation
Fortgeschritten
Budget management
Experte
Risk management
Experte
Vendor and CRO management
Experte
Patient recruitment and retention strategies
Fortgeschritten
Inspection Readiness
Fortgeschritten
Governance frameworks
Fortgeschritten
Change Management
Fortgeschritten
Operational Excellence
Fortgeschritten
Escalation Management
Fortgeschritten

Branchen

Branchen

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