Services

Contact

Address:
Gaea | Clinical Ltd
One Broadcarr Road
Macclesfield
SK11 0AQ
United Kingdom

Gaea Clinical Trial Services LLC
97343, Saint-Petersburg,
ul. Matrosa Zheleznyaka, 57A, 122N

Tel: +44 1625 413 900
Fax: +44 1452 798 222
Mobile: +49 151 51 11 19 31
Email: ngg@gaea.co.uk

Careers

Employment opportunities

Gaea wishes to enhance the UK office team with these two positions. The roles are office based on the Gaea nature reserve office, overlooking the expanse of the Cheshire Plain, outside Macclesfield, a small town that is 30 minutes by train to Manchester and 1.45h to London. There is the opportunity to also work from home. The scope is pan European.

Clinical Trial Manager  

The Clinical Trial Manager (CTM) is responsible for the day-to-day leadership and management of monitoring services for a group of CRAs in a clinical project, including direct communication and interaction with Clinical Trial Associates (CTA), the Clinical Project Manager (CPM), Contracts Attorney, Medical Monitors, providers (such as: safety, regulatory, drug supply, laboratory, data), and with the Sponsor and investigator sites, as required. Gaea works across Europe, including in the Russian Federation.

Duties & Responsibilities

  • Responsible for management of the clinical trial process from project start.
  • Reports to CPM or Director, as designee.
  • Provides project training to CTA/CRA
  • Manage the in-office CTAs and manage CRAs: site assignments, priority and required quality. Performs the assessment of work quality on the basis of key performance indicators.
  • Ensure project consistency within and across projects by following Gaea Clinical and/or Sponsor SOPs and guidelines.
  • In start-up, manage all CRA and CTA tasks – ICF completion and submissions; essential document process flow; TMF requirements; manage SIV processes.
  • Reviews SIV reports for timeliness content and overall quality, manage, resolve issues, and escalation according to the Project Plan.
  • Work with the Contracts Attorney and team on ensuring site contracts and budget delivery via CRAs.
  • Conduct project co-monitoring of CRAs for quality, or need.
  • Involved in audit preparations
  • Communicate with Sponsor and sites as required.
  • May take particular responsibility for a key project specific issue such as pharmacy.
  • Can perform CRA visits when required.

Requirements

  • BSc (in a life science subject), or Qualified as Hospital Pharmacist or with a Nurse Degree, as a minimum. An additional MSc, MBA or other post first-degree qualification is preferred.
  • Oncology or haematology and in-hospital trials in critical care are valuable experiences as these are the complex trials that Gaea manages.
  • Significant experience in clinical trials: from CTA or in- house CRA, through the role as CRA in start-up, monitoring, and close out of complex clinical trials to CTM.
  • Demonstrated skills to focus, train, manage, motivate a Pan-European study team.
  • Excellent interpersonal skills with problem solving and decision- making.
  • Driven to deliver on time to the required quality and to budget.
  • Knowledge of pan European regulatory requirements.
  • Possesses good knowledge of ICH/GCP guidelines.
  • Experienced in a study that was audited is valuable.
  • Proficient in usual Office software.
  • Ability to travel, estimated 10/20% of the time.
 

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