Senior Manager, Study Activation (EU)

Job Title
Senior Manager, Study Activation (EU)
Job ID
27772255
Work Remote
Yes
Location
Remote
Other Location
Description

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure.

 
START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history.

We are seeking a Senior Manager, Study Activation (EU) 

Essential Responsibilities:  

  • Supports SSU strategy in close collaboration with the VP, Client Engagement & Study Activation 

  • Collaborates with central services and site-level study team to ensure SSU timelines and deliverables are met according to internal process, KPIs, and Sponsor goals 

  • Accountable for timely start-up activities until Green Light (ready to initiate site millstone)  

  • Supports study feasibility and site selection milestones in close collaboration with Pre-Award Team as well as the site-level study team. 

  • Supports and directs all study activation milestones in close collaboration with Study Start-up Specialist as well as the site-level study team. 

  • Serves as main contact for issues in SSU phases, escalating as necessary 

  • Ensures sites are prepared for "Green Light" and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site "Green Light" 

  • Oversees EU SSU team activities to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to START standards  

  • Leads EU SSU team meetings and participates in network study team meetings, as required 

  • Contribute to the growth and development of departmental staff, processes and systems. 

  • Ability to embrace HubSpot, Veeva Vault, FileMaker, and CTMS system and associated functionality and maintain records related to specific area of assignment 

  • Assist with in-service trainings and new hire trainings for staff 

  • Assist with special projects as assigned.  This includes, but is not limited to, conducting research, preparing presentations and documents as requested 

  • Serves as a back to the VP and departmental team, when needed 

  • Perform additional duties as assigned 

Required Education and Experience: 

  • BA/BS degree with at least 5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree   

  • Must have knowledge of clinical trial conduct, including, multi-center, global trials. 

  • Experience within the EU-CTR 

  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.  

  • Requires proven project management skills and leadership ability  

  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.  

  • Experience in working cross functionally and with external providers  

  • Experience with development & implementation of process improvement related initiatives  

  • Global Experience with site activation activities including submission requirements.  

Travel Requirements: 

  • Travel: Required to travel up to 20% of the time  

  • Approximately 80% of time is spent sitting. 

  • Very fast-paced and ever-changing healthcare environment. 

  • Demanding deadlines and time frames. 

  • Constant demand for updating knowledge 

 Ready to be part of a team changing the future of cancer treatment?
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.

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