Study Start-Up Specialist

Hobson Prior are currently in search for a Study Start-Up Specialist to join a fast-paced biopharmaceutical organisation who are creating ground-breaking products that have never been made before. The role will be on a permanent basis and to be able to work remotely anywhere across the East Coast USA.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will develop, with the input from the Study team and sites a study-specific SSU plan.
• To forecast submission timelines and certifies they are complied with; by developing a study-specific SSU plan.
• You will complete assigned activities within the US, EU and the UK, that lead to start-up of investigative sites in all phases of clinical trials, while the focus now is on early phases.
• Confirm an efficient start-up process on assigned studies.
• Be the point of contact with Regulatory Authorities and Central/Regional Ethics Committees.
• To interact with sites regarding requirements from RA or other local regulatory parties.
• You will be accountable to the PM and/or Supply Chain Manager at the project level and line manager for deliverables.
• Ensure local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.
• You will develop appropriate early warning systems of potential obstacles to the successful completion of study start up; analyses information and develops innovative solutions to challenges
• Partner with clinical operations and supply chain team to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from the country template. Submits proposed contract and budget for site.
• Work with local IRBs/EC when needed. Must be at least familiar in this process to work with the sites directly
• Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget. Produces site-specific contracts from the country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution
• Any other assigned duties.

Requirements:

• Educated in a Bachelor's degree in a biological or science-related field is essential.
• Previous knowledge of resources required to permit protocol implementation.
• Wide-ranging knowledge of quality assurance related to study start-up.
• Knowledge of electronic data management and issues affecting study start-up.
• At least 3-5 years' experience Study Start-Up in Biotech or Pharma industry.
• Strong experience immune-oncology early phase clinical studies.
• Excellent knowledge of regulation surrounding the collection of tissue and cells.
• Strong knowledge of current clinical trial regulations.
• A valid driving licence.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.