Clinical Research
Aktualisiert am 08.12.2025
Profil
Freiberufler / Selbstständiger
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 Certified (Based in Munich) Limited Working Proficiency
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

Clinical Project Management

Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology US FDA guidelines EMEA guideline GDPR ...
Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology
  • as Clinical Project Manager, directed Phase II oncology study (US/EU, N=300; 6-arms), through recruitment, DBLs and CSRs delivery with < 5% budget variance through proactive risk identification and mitigation
  • Directed 11 vendors across 50+ global sites, embedding TMF completeness and inspection readiness and ensuring full compliance with FDA/EMA standards
  • Managed $70M cumulative study budget with accountability (under budget delivery), integrating forecasts controls
  • Served as primary point of contact and escalation for sponsor, 11 Vendors across EU, US, managing performance metrics, budget forecasting, change-order governance and strategic issue resolution
  • Managed internal and external study teams, including CRAs, Data Managers, Biostatisticians, and site coordinators across 50+ global sites; embedded TMF completeness, inspection readiness and full FDA/EMA and GCP compliance.
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

Management of clinical research

Director- Clinical Research Digital Start up Computerized System Validation Business Development ...
Director- Clinical Research
  • Oversaw multi-trial portfolio in oncology and specialty indications, ensuring regulatory compliance and client success.
  • Launched and scaled a digital platform for Ethics Committee management, boosting operational efficiency and stakeholder collaboration.
  • Led 20+ client portfolios with 90% retention, contributing to 100% revenue achievement and operational expansion 
  • Advised the Indian Society for Clinical Research (ISCR) on national digitalization initiatives for Ethics Committees, contributing to regulatory harmonization across India
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
Quinary Clinical Research - Bangalore (India) (A Tech driven Pharma Start-up Company)
6 Jahre 9 Monate
2013-05 - 2020-01

Global clinical operations ? Biologics ? Rheumatology and oncology

Group Leader Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) ...
Group Leader
  • Directed pivotal Phase III rheumatology trial (N=292) under regulatory pressure, leading to EMA approval.
  • Lead study start-up for multi-region Phase-II study, from RFI to SIV, including vendor selection, feasibility, and site activation.
  • Improved recruitment across Multi Therapeutics studies through a targeted recruitment strategy, achieving full enrollment, enabling the achievement of program goals.
  • Line-managed 5 Project Managers and Clinical Trial Managers for leadership and talent development for global studies
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 Rituximab Trastuzumab Peg Grafeel
Dr. Reddy's Laboratories Ltd.
Hyderabad (India)
5 Jahre 8 Monate
2007-10 - 2013-05

various customer projects

Head of Clinical Operations, Sr PM & PM Kundenbetreuung Profit and Loss Customer escalation management ...
Head of Clinical Operations, Sr PM & PM
  • Directed 40-plus staff across clinical operations (CRA, Team Leads, and Project Manager) and drug supply, with full P&L accountability, consistently meeting financial and delivery targets.
  • Managed successful US FDA inspections across four Neurology sites with zero critical findings- drug approved.
  • Directed oncology, Diabetes, and respiratory indications, contributing to the approvals of Afatinib, Linagliptin and Nintedanib.
  • Integrated cross-border CRO teams, securing 8 projects from top 10 pharma companies and exceeding client expectations
  • Successfully presented Phase 3 Rescued Diabetes study at Biotech's Board Meeting in Washington DC, USA, leading to more projects awarded.
Kundenbetreuung Profit and Loss Customer escalation management Line management Kollaboratives Projektmanagement Project delivery Delivery expansion Performance-Management Coaching Talentmanagement
Manipal AcuNova Ltd (now as Navitas Life Science)
Bangalore (India)
4 Jahre 1 Monat
2003-10 - 2007-10

Monitoring of first-in-use studies

Clinical Research Associate & Scientific Associate site monitoring First in human study Protocol review ...
Clinical Research Associate & Scientific Associate
Monitored First-in-human, SAD/MAD, DDI, food-effect, and early-phase studies, establishing foundational expertise in trial design, safety oversight, and early clinical execution, and enabling IND progression
site monitoring First in human study Protocol review On site monitoring Sponsor co-monitoring DRL-1042 DRF 1644 DRL 10945 RUS 3108
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

Senior Clinical Project manager
  • 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
Clinical Trial management

Profile
Senior Clinical Project Manager with 20+ years of sponsor-dedicated and biotech experience delivering global Phase I, II?III multitherapeutic area trials. Proven expertise in end-to-end relationship management, early-phase trial execution, cross-functional leadership, vendor governance, and full life-cycle trial delivery, ensuring on-time, audit-ready, and compliant outcomes across Europe, North America, and APAC. Track record of regulatory success, early phase trial execution, inspection readiness, and proactive risk management in fast-paced, patient-centric environments.


KEY ACHIEVEMENTS

  • As a CPM, led 300-patient, 6-arms Global Phase II oncology trial on time with recruitment, DB and study reports
  • Directed pivotal Phase III Biosimilar trial (N=292) to EMA approval in 2024 through proactive risk and vendor oversight
  • Led trials across Oncology, Cardiovascular, Rheumatology, Respiratory, Stem cell, Diabetes, covering safety monitoring, GCP compliance in a dynamic environment. Five drugs are approved.
  • Navigated FDA inspection with zero major findings- drug approved
  • Secured 8 repeat EU Global sponsor contracts by consistently delivering on-budget studies with Strategic liaison
  • Managed cumulative study budget of $70 Million with accurate forecasting (less than 5% variance) & Change order control

Tools

  • CTMS (Clinical Trial Management Systems)
  • EDC
  • eTMF (Veeva Vault)
  • Electronic Protocol Development -Veeva Quality/RIMs 
  • MS Office Suite 
  • Project Management Tools (Microsoft Project)

Clinical Trial Management
  • Clinical Project Management 
  • Global Phase I?III Trials 
  • End-to-End Trial coordination (Kick-off through CSR Delivery) 
  • Multi-Therapeutic Area Expertise 
  • Overall Coordination & Monitoring of Clinical Studies 
  • Vendor Oversight & Governance 
  • Budget & Financial Management 
  • Cross-Functional Team Leadership (CRAs, Data Managers, Biostatisticians) 
  • TMF Management & Data Integrity 
  • Audit & Inspection Readiness 
  • Risk & Issue Management

Regulatory & Compliance
  • ICH-GCP 
  • EU-CTR 536/2014 
  • FDA 21 CFR Part 11 
  • EMA Guidelines 
  • Inspection Readiness (FDA, EMA) 
  • CAPA Development & Oversight 
  • Protocol Compliance

Klinische Forschung

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

Branchen

Branchen

Einsatzorte

Einsatzorte

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

Projekte

Projekte

3 Jahre 4 Monate
2022-02 - 2025-05

Clinical Project Management

Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology US FDA guidelines EMEA guideline GDPR ...
Associate Director - Clinical Trial Leader-Global Clinical Operation- Oncology
  • as Clinical Project Manager, directed Phase II oncology study (US/EU, N=300; 6-arms), through recruitment, DBLs and CSRs delivery with < 5% budget variance through proactive risk identification and mitigation
  • Directed 11 vendors across 50+ global sites, embedding TMF completeness and inspection readiness and ensuring full compliance with FDA/EMA standards
  • Managed $70M cumulative study budget with accountability (under budget delivery), integrating forecasts controls
  • Served as primary point of contact and escalation for sponsor, 11 Vendors across EU, US, managing performance metrics, budget forecasting, change-order governance and strategic issue resolution
  • Managed internal and external study teams, including CRAs, Data Managers, Biostatisticians, and site coordinators across 50+ global sites; embedded TMF completeness, inspection readiness and full FDA/EMA and GCP compliance.
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

Management of clinical research

Director- Clinical Research Digital Start up Computerized System Validation Business Development ...
Director- Clinical Research
  • Oversaw multi-trial portfolio in oncology and specialty indications, ensuring regulatory compliance and client success.
  • Launched and scaled a digital platform for Ethics Committee management, boosting operational efficiency and stakeholder collaboration.
  • Led 20+ client portfolios with 90% retention, contributing to 100% revenue achievement and operational expansion 
  • Advised the Indian Society for Clinical Research (ISCR) on national digitalization initiatives for Ethics Committees, contributing to regulatory harmonization across India
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
Quinary Clinical Research - Bangalore (India) (A Tech driven Pharma Start-up Company)
6 Jahre 9 Monate
2013-05 - 2020-01

Global clinical operations ? Biologics ? Rheumatology and oncology

Group Leader Biosimilar Development Line management Clinical Trial Management (Phase 1- IV) ...
Group Leader
  • Directed pivotal Phase III rheumatology trial (N=292) under regulatory pressure, leading to EMA approval.
  • Lead study start-up for multi-region Phase-II study, from RFI to SIV, including vendor selection, feasibility, and site activation.
  • Improved recruitment across Multi Therapeutics studies through a targeted recruitment strategy, achieving full enrollment, enabling the achievement of program goals.
  • Line-managed 5 Project Managers and Clinical Trial Managers for leadership and talent development for global studies
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 Rituximab Trastuzumab Peg Grafeel
Dr. Reddy's Laboratories Ltd.
Hyderabad (India)
5 Jahre 8 Monate
2007-10 - 2013-05

various customer projects

Head of Clinical Operations, Sr PM & PM Kundenbetreuung Profit and Loss Customer escalation management ...
Head of Clinical Operations, Sr PM & PM
  • Directed 40-plus staff across clinical operations (CRA, Team Leads, and Project Manager) and drug supply, with full P&L accountability, consistently meeting financial and delivery targets.
  • Managed successful US FDA inspections across four Neurology sites with zero critical findings- drug approved.
  • Directed oncology, Diabetes, and respiratory indications, contributing to the approvals of Afatinib, Linagliptin and Nintedanib.
  • Integrated cross-border CRO teams, securing 8 projects from top 10 pharma companies and exceeding client expectations
  • Successfully presented Phase 3 Rescued Diabetes study at Biotech's Board Meeting in Washington DC, USA, leading to more projects awarded.
Kundenbetreuung Profit and Loss Customer escalation management Line management Kollaboratives Projektmanagement Project delivery Delivery expansion Performance-Management Coaching Talentmanagement
Manipal AcuNova Ltd (now as Navitas Life Science)
Bangalore (India)
4 Jahre 1 Monat
2003-10 - 2007-10

Monitoring of first-in-use studies

Clinical Research Associate & Scientific Associate site monitoring First in human study Protocol review ...
Clinical Research Associate & Scientific Associate
Monitored First-in-human, SAD/MAD, DDI, food-effect, and early-phase studies, establishing foundational expertise in trial design, safety oversight, and early clinical execution, and enabling IND progression
site monitoring First in human study Protocol review On site monitoring Sponsor co-monitoring DRL-1042 DRF 1644 DRL 10945 RUS 3108
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

Senior Clinical Project manager
  • 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
Clinical Trial management

Profile
Senior Clinical Project Manager with 20+ years of sponsor-dedicated and biotech experience delivering global Phase I, II?III multitherapeutic area trials. Proven expertise in end-to-end relationship management, early-phase trial execution, cross-functional leadership, vendor governance, and full life-cycle trial delivery, ensuring on-time, audit-ready, and compliant outcomes across Europe, North America, and APAC. Track record of regulatory success, early phase trial execution, inspection readiness, and proactive risk management in fast-paced, patient-centric environments.


KEY ACHIEVEMENTS

  • As a CPM, led 300-patient, 6-arms Global Phase II oncology trial on time with recruitment, DB and study reports
  • Directed pivotal Phase III Biosimilar trial (N=292) to EMA approval in 2024 through proactive risk and vendor oversight
  • Led trials across Oncology, Cardiovascular, Rheumatology, Respiratory, Stem cell, Diabetes, covering safety monitoring, GCP compliance in a dynamic environment. Five drugs are approved.
  • Navigated FDA inspection with zero major findings- drug approved
  • Secured 8 repeat EU Global sponsor contracts by consistently delivering on-budget studies with Strategic liaison
  • Managed cumulative study budget of $70 Million with accurate forecasting (less than 5% variance) & Change order control

Tools

  • CTMS (Clinical Trial Management Systems)
  • EDC
  • eTMF (Veeva Vault)
  • Electronic Protocol Development -Veeva Quality/RIMs 
  • MS Office Suite 
  • Project Management Tools (Microsoft Project)

Clinical Trial Management
  • Clinical Project Management 
  • Global Phase I?III Trials 
  • End-to-End Trial coordination (Kick-off through CSR Delivery) 
  • Multi-Therapeutic Area Expertise 
  • Overall Coordination & Monitoring of Clinical Studies 
  • Vendor Oversight & Governance 
  • Budget & Financial Management 
  • Cross-Functional Team Leadership (CRAs, Data Managers, Biostatisticians) 
  • TMF Management & Data Integrity 
  • Audit & Inspection Readiness 
  • Risk & Issue Management

Regulatory & Compliance
  • ICH-GCP 
  • EU-CTR 536/2014 
  • FDA 21 CFR Part 11 
  • EMA Guidelines 
  • Inspection Readiness (FDA, EMA) 
  • CAPA Development & Oversight 
  • Protocol Compliance

Klinische Forschung

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

Branchen

Branchen

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