Salary:
NegotiableJob type:
Interim/ContractLocation:
Function:
Clinical Operations, Project ManagementRef:
Hobson Prior are partnering with a brilliant pharmaceutical organisation who are currently looking for an individual to join their team on a contract basis. Our client is focused on delivering treatments that improve the lives of many. The opening position is for a Assoc Princ Specialist Study Management.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- For this role, you will guide and enable communication across all functions, which involves external partners and service providers.
- Guarantee studies are always inspection-ready, rendering to ICH-GCP and company SOP and pertinent policies/regulations.
- Offer contributions into and hold responsible for the development of necessary study level documents such as CSP through to CSR rendering to pertinent company SOPs.
- Responsible for guaranteeing that information in all systems is utilised at a study-level presently and precisely.
- Supervise TMF accomplishment rendering to company SOPs, which involves guaranteeing the TMF plan and EDL are in place and that QC actions are conducted on an ongoing basis to always guarantee TMF accomplishment.
- Assure compliance with company-wide governance controls such as Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency, etc in a timely manner.
- Any other assigned duties.
Key Skills:
- Leadership skills.
- Works well with others with solid conflict management abilities.
- Interpersonal and communication skills both verbally and in writing.
- Able to think methodically and critically.
- An organised individual with the ability to resolve issues.
- Capable of handling competing priorities.
Requirements:
- Educated to a degree level in a medical or biological science ideally, with clinical research such as a pharmacist role, doctoral degree in drug development.
- At least 5 years of experience in clinical within a pharmaceutical organisation, which involves at least 2 years of experience in project management or a mixture of education, training and experience.
- Comprehension of the whole drug process.
- Know-how of ICH-GCP, clinical research regulatory needs and exhibited abilities in clinical study management procedures and clinical/drug development.
- Project management abilities and expertise on pertinent tools.
- Familiarity with all phases of a clinical study lifecycle would be ideal.
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.
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