Simbec Orion Group Ltd

Associate Project Manager

Remote, UK
18 Jun 2021
07 Jul 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

Summary of the Position:

We are looking for an Associate Project Manager to join our Project Management department.

You will support Project Managers on aspects of phase I-IV patient clinical studies from start-up to close-out, according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs), ICH-GCP and local regulations. You will act as a Project Manager on small "non-complex" studies with one or two services, overseeing the Clinical Research Associates allocated to the study and acting as a back-up to the Project Manager.

You will contribute to Clinical Trials being conducted with optimal quality, on time and on budget such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable by working with the PM, other service leads such Clinical Team Lead, Data Management Lead, Medical Monitoring Lead and vendors.

Key Accountabilities:
  • Serve as the primary project contact with the Sponsor on smaller projects and act as the back-up for Project Managers on larger projects.
  • Support the Project Manager in managing aspects of a clinical trial such as vendor management, finances, team meetings and coordinating a service.
  • Create, track, and report on project timeline to measure against baseline and report progress to the Sponsor and internally to allow actions/decisions to be taken if the project is off track.
  • Assist the Project Manager with budget allocation and approval of invoices.
  • Record Actions / Decisions / Minutes of team meetings as required by Simbec-Orion SOPs and Good Clinical Practice.
  • Coordinate data gathering for out of scope work for input into a change order to ensure that Simbec-Orion is paid for work all work conducted.
  • Develop study management plans in collaboration with service leads and support from the Project Manager.
  • Prepare and present project information at internal and external meetings with support from the Project Manager.
  • Help identify project risks and support issue resolution to maximise the chances of delivering the project with high quality, on budget and on time.

Minimum Requirements:

  • Degree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience
  • Previous experience within Project Management in a supporting role or leading other service areas within Clinical Research
  • Experience with Phase 1- III patient studies either as an Associate Project Manager or in a lead role in clinical, data management, pharmacovigilance or regulatory
  • Strong communication skills and ability to present in Fluent English
  • In depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.

  • Experienced with using tools such as eTMF and CTMS
  • Basic knowledge of project finances such as tracking of investigator fees, pass through costs and concept of revenue recognition
  • Worked within a CRO environment
  • Experience of supporting full-service projects from start-up to close-out

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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