• Contract
  • Bayern
  • Recruiter: Ashwini Shirvaikar

The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client is an innovative global biopharmaceutical leader aiming to improve the lives of patients suffering from serious diseases.

We are currently looking for a Clinical Trial Lead, to be located in Munich area.

Main Responsibilities: 

  • Leads the global cross-functional Clinical Trial Team
  • Provides direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
  • Ensures trial operational plans are developed by the vendors with inputs from CTT
  • Develops and executes operational risk management plan highlighting potential risks and actions
  • Creates and drives trial level timelines and deliverables
  • Ensures all trial related documents and systems (e.g. clinical database, IRT and etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines
  • Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the signed contract and agreed timelines and budget
  • Reports and assesses vendor performance ongoing during the trial
  • Collaborates with Clinical Trial Supply Management and vendors to ensure all aspects of the IMP and non-drug supplies (if applicable) are managed throughout the trial
  • Manages and oversees resolution of trial operational issues
  • Collects, tracks, and communicates trial status to the relevant internal/external boards
  • Accountable for accuracy of trial information in all trial databases, trial master file, and tracking systems
  • Manages trial budget, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out
  • Participates in inspection/audit and ensures timely response to inspection/audit observations or other quality issues in cooperation with Quality Assurance
  • Collaborates with CTT to define the scope of responsibilities of operational and medical/clinical data review within the data management plan or equivalent to ensure ongoing quality data review

Qualifications and Experience: 

  • Ideally a minimum of five years operational experience in planning / executing / reporting clinical trials on international level
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process
  • Experience with health authority inspections (FDA and / or EMEA) preferred
  • Demonstrated ability to effectively manage trial budget
  • Strong leadership and project management skills in a cross functional and multicultural team
  • Excellent in negotiation and conflict resolution
  • Fluent English (oral and written)

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.