Clinical Trial Associate

SoseiHeptares Cambridge United Kingdom Biotech

Company Description

Sosei Heptares (the corporate brand of Sosei Group Corporation) is a research-focused biotechnology group, publicly listed in Japan (TSE: 4565) and with sites in Tokyo, London and Cambridge (UK).

Our mission is to make a significant contribution to improving the quality of life and health of people around the world. To achieve this, we will discover, design and develop the most innovative and effective medicines for patients worldwide, through our world-leading patent-protected technology and platform.

Our primary focus is the discovery and early development of new medicines originating from our proprietary G Protein-Coupled Receptor (GPCR)-targeted StaR® technology and Structure-Based Drug Design (SBDD) platform capabilities. The company is advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications.

Our Company has established partnerships with some of the world’s leading pharmaceutical companies, including AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Novartis, Pfizer and Takeda and additionally with multiple emerging technology companies. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

Sosei Heptares has approximately 170 employees based at its new R&D research facility at Granta Park. The size of the company ensures a transparent linkage between all activities from early discovery through to clinical development.

Position

To provide support for colleagues in Clinical Operations and in Development towards the planning, preparation, conduct and reporting of clinical trials. Activities are not limited and could include organisation of clinical study documentation (including Trial Master File), financial and vendor management, organising contracts, maintaining data and systems, supporting meetings and other clinical study related activities.

Reports to: Head of Clinical Operations

Key responsibilities

Working with Project and/or Clinical Trial Leaders (and others in Development) in the following activities (responsibility for certain activities may be delegated):

General Development Activities

  • Contracts, Vendor Management and Finance
    • Support towards drafting and issuing legal and controlled documents (e.g. CDAs, MSAs, Contracts, Work and Change Orders, Consultancy Agreements).
    • Assistance in identifying and oversight/management of Vendors.
  • Systems and Tracking Tools
    • Support use of clinical trial dictionaries (e.g. MedDRA, WHO).
    • Support with external clinical trial databases (e.g. EudraCT, clinicaltrials.gov)
    • Collection and maintenance of data relating to clinical trials.

Clinical Trial Activities

  • Set-up conduct and reporting of clinical trials.
    • Support clinical trial activities (e.g. study and site feasibility, site in-house monitoring, study patient/volunteer recruitment, training materials, tracking of trial progress).
    • Creation and maintenance of Trial Master Files and/or Study Oversight Files to inspection ready (GCP) standards.
      • Collection of electronic and physical documents/records which must be filed in a controlled environment.
      • Tracking, filing and archiving of essential documents.
    • Assistance with clinical study budget and forecasting, financial aspects, invoice tracking and accruals.

Other Activities

  • Meetings (Internal, Functional, KOL, Investigator etc.).
    • Organisation and support for meetings (telecons and off-site).
    • Preparation and circulation of meeting documentation (agenda and minutes).

Requirements

  • BSc in a scientific discipline.
  • Experience of working in a scientific organisation (preferably Pharma or drug research/development).
  • Ability to work in regulated environments requiring compliance with standard operating procedures, controlled document storage and/or regulatory compliance.(Knowledge of ICH-GCP guidelines where relevant).
  • Good communication skills, ensuring communications are professional and courteous.
  • Experience of financial/contract support.
  • Computer literacy including familiarity with Microsoft Office and other applications.
  • Accuracy, with good attention to detail.
  • Good organisational and administrative skills and an aptitude for forward planning and prioritisation. Proactive and use of initiative with a positive creative attitude.
  • Ability to manage a varied workload successfully and the ability to multi-task.
  • Can work independently or as part of a team.
  • Ability to exercise sound judgment and maintain confidentiality in all aspects of the role.

This is an evolving role and the above list of responsibilities is not exhaustive; the postholder may be requested to assume additional duties, as might reasonably be required.

Other information

We offer a competitive salary and benefits package commensurate with qualifications and experience.

Heptares is an equal opportunities employer.

Applications should include a covering letter, providing a short description of the background to their interest in the role, with curriculum vitae including the names and contact details for two referees. Please apply through our on-line jobs portal with your application in pdf format, quoting reference number Dev003. The closing date for applications is 23rd May 2021.

Sosei Heptares does not accept speculative or unsolicited CVs from agencies. All speculative or unsolicited CVs submitted without an agreement in place will be considered Sosei Heptares’ property and will not obligate us to pay a referral fee.

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