Clinical Project Management. Oncology Clinical Trial. Clinical Operation. Regulatory Inspection.
Aktualisiert am 20.06.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.07.2025
Verfügbar zu: 100%
davon vor Ort: 100%
Clinical Operation
Project Management
Vendor and budget management
Risk Management
FDA/EMA GCP Inspection
Stake Holder Management
Cross Functional Team Engagement
Patient Recruitment
Qualitymanagement
TMF management
English
Full Professional Proficiency
German
Limited Working Proficiency-B1

Einsatzorte

Einsatzorte

Munich (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 years 5 months
2019-02 - now

Integrated a large Phase 3 oncology clinical trial

Associate Director: Clinical Trial Lead
Associate Director: Clinical Trial Lead
  • Integrated a large Phase 3 oncology clinical trial (n=430) in MorphoSys' QMS system post-acquisition of Constellation Pharmaceuticals, ensured seamless business operations and maintained regulatory compliance
  • Delivered primary data analysis on time under stringent timelines and collaborated with CTT and senior leadership to oversee CRO and 7 vendors , achieving critical clinical milestones that enabled successful presentation of trial results at ASH 2023 and played a pivotal role in facilitating a $2.7B acquisition deal for the company
  • Accelerated patient recruitment by integrating two regional CROs into a high-priority Phase 3 oncology trial in Myelofibrosis, achieving recruitment targets six months ahead of schedule in a challenging indication
  • Established and led the first-ever Clinical Research Medical Advisor team across three global regions to enhance patient recruitment efforts?marking a first in MorphoSys' history
  • Applied strict budget control and financial discipline to ensuring year-over-year cost variances were avoided ( total study budget 240 mUSD)
  • Enhanced vendor and resource allocation strategies to align with company goals, resulting in successful achievement of recruitment targets, database lock, data quality and inspection readiness.
  • Maintained inspection readiness by consistently updating the Trial Master File (TMF) and storyboards
  • Proactively communicated critical risks regarding data quality and financial management to GPT and DLT teams for prompt mitigation
Morphosys AG
Munich-Germany
3 years 7 months
2016-02 - 2019-08

Led the successful intercompany transfer

Sr. Clinical Trial Lead
Sr. Clinical Trial Lead
  • Led the successful intercompany transfer of a large Phase 3 oncology clinical trial (n=650) and established a new Clinical Trial Team (CTT) structure within Sandoz to ensure seamless operational continuity.
  • Collaborated cross-functionally with CTT members, Quality Assurance, and key stakeholders to ensure the Trial Master File (TMF) was inspection-ready, storyboards were completed, and the CTT was thoroughly trained for regulatory inspections.
  • Successfully directed CTT preparations and represented during PMDA (Japan), EMEA, and US FDA inspections - both at sponsor offices and clinical sites - resulting in positive outcomes with Zero critical finding
  • Directed a cross-functional global team operating across three time zones to deliver the Clinical Study Report (CSR) and multiple safety data cuts in response to post-submission requests from various regulatory authorities, contributing to subsequent regulatory approvals across several markets
  • Assured compliant and timely study closure, overseeing final reconciliations of vendor contracts and the archiving of all study documents in accordance with company quality standards
Hexal AG
Munich
2 years 10 months
2013-04 - 2016-01

Execution of 2 global clinical studies valued

Sr. Clinical Project Manager
Sr. Clinical Project Manager
  • Led the successful execution of 2 global clinical studies valued at over $30M, ensuring on-time delivery within budget while maintaining protocol compliance and audit readiness
  • Developed and implemented integrated study management plans in collaboration with cross-functional teams, reducing study start-up timelines by 20%
  • Oversaw project risk management and resolved over critical issues, implementing proactive contingency strategies that minimized delays and preserved $2.5M in projected revenue
  • Built and managed cross-functional teams of up to 30 members across global locations, increasing milestone adherence by 30% through improved coordination and performance tracking
  • Participated in several bid-defenses and worked closely with team to won contracts worth $60M
Quintiles
Ahmedabad-India
2 years 10 months
2008-01 - 2010-10

Project planning, performance monitoring

Project Manager
Project Manager
  • Managed project planning, performance monitoring, and team development across multiple time zones
  • Developed and executed risk and quality management strategies to uphold regulatory standards
Siro Clinpharm Pvt Ltd
Mumbai-India
2 years 1 month
2006-01 - 2008-01

Development and implementation of clinical management strategies

Clinical Team Leader
Clinical Team Leader
  • Led the development and implementation of clinical management strategies, conducted site training, and ensured quality oversight for Phase III studies
  • Demonstrated ability to ensure timely resolution of data queries and escalations through effective communication and problem-solving skills
Lambda Therapeutic Research Ltd
Ahmedabad-India
2 years 7 months
2003-07 - 2006-01

Developement study protocols and finalized study reports

Clinical Research Officer
Clinical Research Officer
  • Developed study protocols and finalized study reports for regulatory submissions 
  • Conducted monitoring activities for phase III clinical trials focusing on Novel Drug Delivery Systems (NDDS)
  • Conducted feasibility and site qualification visits to assess project viability and site suitability 
  • Led site initiation visits, monitoring visits, and site closeout visits for projects
Sun Pharmaceutical Industries Ltd
Baroda-India
1 year 1 month
2002-07 - 2003-07

Management sites for phase III clinical trials including coordination

Product Specialist
Product Specialist
  • Managed sites for phase III clinical trials including coordination of activities, monitoring progress, and ensuring compliance with protocols
  • Prepared and submitted documents for ethics committee review
  • Managed site initiation, monitoring, and closeout visits in adherence to study timeline
Intas Pharmaceutical Ltd
Ahmedabad-India

Aus- und Weiterbildung

Aus- und Weiterbildung

1 month
2011-01 - 2011-01

Certified Project Management Professional (PMP)

Project Management Institute (PMI) USA, India
Project Management Institute (PMI) USA, India
1 month
2004-01 - 2004-01

Masters Diploma in Business Administration (MDBA)

Symbiosis Institute of Management Studies, India
Symbiosis Institute of Management Studies, India
1 month
2002-07 - 2002-07

Master of Pharmacy (Pharmacology)

Gujarat University, India
Gujarat University, India

Kompetenzen

Kompetenzen

Top-Skills

Clinical Operation Project Management Vendor and budget management Risk Management FDA/EMA GCP Inspection Stake Holder Management Cross Functional Team Engagement Patient Recruitment Qualitymanagement TMF management

Produkte / Standards / Erfahrungen / Methoden

Profile

Certified PMP® with over 20 years of clinical trial management experience in both Sponsor and CRO environments. Skilled in global project execution, vendor oversight, and patient recruitment, with a track record of exceeding enrollment targets ahead of schedule. Proficient in financial management, timeline optimization, and effective stakeholder communication to ensure high-quality clinical outcomes. 


KEY SKILLS

  • Clinical Operation
  • Project Management & Integration
  • Vendor and Budget Management
  • Cross Functional Team Engagement
  • Quality by Design
  • Risk Management
  • FDA/EMEA Inspections
  • Stakeholder management
  • Problem Solving

Einsatzorte

Einsatzorte

Munich (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 years 5 months
2019-02 - now

Integrated a large Phase 3 oncology clinical trial

Associate Director: Clinical Trial Lead
Associate Director: Clinical Trial Lead
  • Integrated a large Phase 3 oncology clinical trial (n=430) in MorphoSys' QMS system post-acquisition of Constellation Pharmaceuticals, ensured seamless business operations and maintained regulatory compliance
  • Delivered primary data analysis on time under stringent timelines and collaborated with CTT and senior leadership to oversee CRO and 7 vendors , achieving critical clinical milestones that enabled successful presentation of trial results at ASH 2023 and played a pivotal role in facilitating a $2.7B acquisition deal for the company
  • Accelerated patient recruitment by integrating two regional CROs into a high-priority Phase 3 oncology trial in Myelofibrosis, achieving recruitment targets six months ahead of schedule in a challenging indication
  • Established and led the first-ever Clinical Research Medical Advisor team across three global regions to enhance patient recruitment efforts?marking a first in MorphoSys' history
  • Applied strict budget control and financial discipline to ensuring year-over-year cost variances were avoided ( total study budget 240 mUSD)
  • Enhanced vendor and resource allocation strategies to align with company goals, resulting in successful achievement of recruitment targets, database lock, data quality and inspection readiness.
  • Maintained inspection readiness by consistently updating the Trial Master File (TMF) and storyboards
  • Proactively communicated critical risks regarding data quality and financial management to GPT and DLT teams for prompt mitigation
Morphosys AG
Munich-Germany
3 years 7 months
2016-02 - 2019-08

Led the successful intercompany transfer

Sr. Clinical Trial Lead
Sr. Clinical Trial Lead
  • Led the successful intercompany transfer of a large Phase 3 oncology clinical trial (n=650) and established a new Clinical Trial Team (CTT) structure within Sandoz to ensure seamless operational continuity.
  • Collaborated cross-functionally with CTT members, Quality Assurance, and key stakeholders to ensure the Trial Master File (TMF) was inspection-ready, storyboards were completed, and the CTT was thoroughly trained for regulatory inspections.
  • Successfully directed CTT preparations and represented during PMDA (Japan), EMEA, and US FDA inspections - both at sponsor offices and clinical sites - resulting in positive outcomes with Zero critical finding
  • Directed a cross-functional global team operating across three time zones to deliver the Clinical Study Report (CSR) and multiple safety data cuts in response to post-submission requests from various regulatory authorities, contributing to subsequent regulatory approvals across several markets
  • Assured compliant and timely study closure, overseeing final reconciliations of vendor contracts and the archiving of all study documents in accordance with company quality standards
Hexal AG
Munich
2 years 10 months
2013-04 - 2016-01

Execution of 2 global clinical studies valued

Sr. Clinical Project Manager
Sr. Clinical Project Manager
  • Led the successful execution of 2 global clinical studies valued at over $30M, ensuring on-time delivery within budget while maintaining protocol compliance and audit readiness
  • Developed and implemented integrated study management plans in collaboration with cross-functional teams, reducing study start-up timelines by 20%
  • Oversaw project risk management and resolved over critical issues, implementing proactive contingency strategies that minimized delays and preserved $2.5M in projected revenue
  • Built and managed cross-functional teams of up to 30 members across global locations, increasing milestone adherence by 30% through improved coordination and performance tracking
  • Participated in several bid-defenses and worked closely with team to won contracts worth $60M
Quintiles
Ahmedabad-India
2 years 10 months
2008-01 - 2010-10

Project planning, performance monitoring

Project Manager
Project Manager
  • Managed project planning, performance monitoring, and team development across multiple time zones
  • Developed and executed risk and quality management strategies to uphold regulatory standards
Siro Clinpharm Pvt Ltd
Mumbai-India
2 years 1 month
2006-01 - 2008-01

Development and implementation of clinical management strategies

Clinical Team Leader
Clinical Team Leader
  • Led the development and implementation of clinical management strategies, conducted site training, and ensured quality oversight for Phase III studies
  • Demonstrated ability to ensure timely resolution of data queries and escalations through effective communication and problem-solving skills
Lambda Therapeutic Research Ltd
Ahmedabad-India
2 years 7 months
2003-07 - 2006-01

Developement study protocols and finalized study reports

Clinical Research Officer
Clinical Research Officer
  • Developed study protocols and finalized study reports for regulatory submissions 
  • Conducted monitoring activities for phase III clinical trials focusing on Novel Drug Delivery Systems (NDDS)
  • Conducted feasibility and site qualification visits to assess project viability and site suitability 
  • Led site initiation visits, monitoring visits, and site closeout visits for projects
Sun Pharmaceutical Industries Ltd
Baroda-India
1 year 1 month
2002-07 - 2003-07

Management sites for phase III clinical trials including coordination

Product Specialist
Product Specialist
  • Managed sites for phase III clinical trials including coordination of activities, monitoring progress, and ensuring compliance with protocols
  • Prepared and submitted documents for ethics committee review
  • Managed site initiation, monitoring, and closeout visits in adherence to study timeline
Intas Pharmaceutical Ltd
Ahmedabad-India

Aus- und Weiterbildung

Aus- und Weiterbildung

1 month
2011-01 - 2011-01

Certified Project Management Professional (PMP)

Project Management Institute (PMI) USA, India
Project Management Institute (PMI) USA, India
1 month
2004-01 - 2004-01

Masters Diploma in Business Administration (MDBA)

Symbiosis Institute of Management Studies, India
Symbiosis Institute of Management Studies, India
1 month
2002-07 - 2002-07

Master of Pharmacy (Pharmacology)

Gujarat University, India
Gujarat University, India

Kompetenzen

Kompetenzen

Top-Skills

Clinical Operation Project Management Vendor and budget management Risk Management FDA/EMA GCP Inspection Stake Holder Management Cross Functional Team Engagement Patient Recruitment Qualitymanagement TMF management

Produkte / Standards / Erfahrungen / Methoden

Profile

Certified PMP® with over 20 years of clinical trial management experience in both Sponsor and CRO environments. Skilled in global project execution, vendor oversight, and patient recruitment, with a track record of exceeding enrollment targets ahead of schedule. Proficient in financial management, timeline optimization, and effective stakeholder communication to ensure high-quality clinical outcomes. 


KEY SKILLS

  • Clinical Operation
  • Project Management & Integration
  • Vendor and Budget Management
  • Cross Functional Team Engagement
  • Quality by Design
  • Risk Management
  • FDA/EMEA Inspections
  • Stakeholder management
  • Problem Solving

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