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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.
- 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)
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