study start up project manager.

Are you an experienced Study Start Up Project Manager? Do you have experience with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations? If so, we would love to speak with you!

The successful candidate will join our clients Clinical Trial Accelerator Unit, taking broad responsibility for accelerating Study Start Up activities, harmonizing processes and providing start-up expertise to studies and programs to which they are assigned. They will also ensure study teams meet and exceed the final protocol to the first patient in timelines and ensure all sites in the study are activated on time.

This is a contract position, offered initially for 6 months (likely to be extended beyond 12 months+) based out of our client's site in Maidenhead. There is flexibility for both hybrid and remote working for the right candidate.

Responsibilities:

• This role is predominantly an oversight role and works in close collaboration with the Clinical Trial Lead who has overall accountability for the study
• The Study Start Up Project Manager is responsible for ensuring that Study Start Up and site activation deliverables are achieved in a timely and efficient manner, compliant with SOPs and procedural documents, applicable local regulations and international guidelines such as ICH and GCP
• Tasks vary from study to study but include building out a MS Project plan for all activities and holding the team accountable for task driven progress, maintaining the Quantitative Science and Development Operations study dashboard, as well as closely monitoring individual site activations
• Other activities the SSU PM may get involved in include: Feasibility, Site Selection, Site contracting and budgets, Vendor set-up, Informed Consent management, and overall site engagement
• May support special projects, develop templates, materials and processes or perform other assigned tasks as needed

Experience and skills:

• BA or BS in a scientific discipline (advanced degree preferred)
• Scientifically and clinically astute with very strong project management skills
• Good knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
• At least 5 years of clinical research experience of which at least 3 years of Study Start Up management experience with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations
• Prior CRO or investigator site and/or monitoring experience is a plus
• Proficiency in MS Project
• Advance use of MS Excel
• Previous use of Veeva CTMS and Study Start Up module would be ideal
• Good organizational and time management skills
• Good communication and interpersonal skills
• Good negotiation skills
• Ability to work in a matrix environment

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.