Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!

If you are looking to take on responsibility and leverage your know-how in the start-up phase of clinical trials - ensuring a successful start of important clinical studies in the UK -, this is the perfect opportunity. You will be working alongside our dedicated and supportive team of SSU experts and exclusively for one of our renowned international sponsors - in a role that allows you to have a real impact on people's health and lives.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

This role can be a mix of home-based and Office based, and as such you must be based in the South East of England.

Your tasks:

• Independently manages multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
• Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
• Collaborates with other internal roles in country feasibility and site selection.
• Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
• Prepare country Informed Consent Form (ICF) and manage country ICF template
• Review and approval of Site ICFs
• Review and approval of Clinical Trial Package (CTP) documentation
• Update national registries as applicable
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
• When applicable, conduct drug/IMP label review & translation
• Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
• May support the collection and distribution of documents from / to sites including obtaining insurance certificates
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

Education:

• Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, oecotrophology etc.,
  
• In lieu of the above, an equivalent completed vocational education or equivalent professional experience
  

Experience:

• Solid expertise in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory processes
  
• Demonstrated understanding of research protocol requirements as well as the ability to communicate them / educate others about them
  
• Proven track record collaborating successfully with operational project teams as well as external investigative sites and local regulatory authorities (including IRBs and IECs)
  
• In-depth experience with submissions to the UK regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP
  
• Familiarity with investigator start-up documents and contract / budget negotiation processes with study sites
  
• Autonomous work style with excellent time and project management skills
  
• Business fluency in English - both spoken and written - is a must
  

REMOTE

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