Opportunity to join a top pharma that in 25 years, has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 6,000 employees in offices across four continents. Today, the research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Our therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Chance to join this Global Pharma on a freelance basis, paying competitive salaries. The position will be hybrid working: Leading cross-functional study teams for the delivery of global clinical trials. Managing all services that bring together a complete study/drug development lifecycle – acting as the main point of contact for Regulatory Affairs, Quality Assurance, Clinical Operations, Data Management and Safety. Establishing innovative approaches to resolve issues.
Searching for someone who has proven experience in clinical development in a global setting.
- Assist in revision of Site Budgets and manages Investigator and Site Payments.
- Participate in preparation and presentation of bid defense or any other study related meetings.
- Management of study Vendors/CROs as required.
- Develop and deliver project-specific training and provides input to Project Specific Training Matrix
- Monitor and manage trial materials supplies. Ensures Investigational Product and other study supplies are shipped to sites.
- Review study systems (CTMS, CRF, IRS, central lab portal, etc) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct.
- A degree in life sciences or nursing qualification preferred
- A minimum of 6 years clinical research experience in the Pharma industry
- 1 yr CTM or other relevant team leadership experience
- Ability to mentor and train other CRAs in a positive and effective manner
- Oncology/Cell Therapy experience is essential
- Must have multinational (preferably EU) clinical trials experience including study management/coordination.
- Monitoring experience highly desirable as site oversight monitoring visits will be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Must have a general, functional expertise to support SOP development and implementation.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- International travel is required (up to approximately 20%)
Location: London (Hybrid)
Length of contract: 12 months (likely to be extended)
This Role is an urgent need. So, the processes for these roles are moving very quickly so if there is an interest, we will need to move fast to ensure you don’t miss out.
These positions will be snapped up, looking for individuals who are ambitious, positive and want to work in a growing and exciting team.
Do not miss out on this opening – apply below or contact Kush at Meet on 0203 0195957 or email directly to firstname.lastname@example.org
You can find out more about Kush & Meet at www.peoplewithchemistry.com