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Associate Project Manager - Clinical Pharmacology

Employer
Simbec-Orion
Location
Merthyr Tydfil, United Kingdom
Salary
Competitive
Start date
9 Aug 2022
Closing date
3 Sep 2022

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Job Details

ABOUT US

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.

THE ROLE

We are looking for an Associate Project Manager to join our Project Management - Clinical Pharmacology team where you will assist with the planning and management of Clinical Pharmacology trials at Simbec-Orion, including advising on trial design and methodology. You will support the preparation of key trial documents, such as protocols, patient information leaflets, and regulatory applications and you will ensure that clinical trials are conducted on time, on budget, and according to SOPs, ICH-GCP, and local regulations that meet high-quality standards and contract specifications.

KEY ACCOUNTABILITIES

  • Assist in the conduct and management of all projects to the standards of Good Clinical Practice (ICH-GCP) and in accordance with Standard Operating Procedures (SOPs), the UK Statutory Instrument No. 1031 (The Medicines for Human Use [Clinical Trials] Regulations 2004 and subsequent amendments) and applicable guidelines to meet Clients expectations.
  • Take part in discussions with clients and sub-contractors regarding the project (including study design, feasibility, budgets and timeframes).
  • Maintain awareness of current guidelines and advances in clinical research to support discussions with clients, internal stakeholders and sub-contractors.
  • Assist in keeping the client and internal stakeholders informed of project progress (including attending meetings and taking minutes).
  • Assist in the preparation of protocols and protocol amendments.
  • Assist with the preparation of submission documents for the Research Ethics Committee and Competent Authority.
  • Set up, maintain and archive the Investigator Site File (ISF) and Trial Master File (TMF).
  • Assist with the generation of study documents and perform departmental quality control duties.
  • Assist when necessary with clinical procedures, i.e., dosing of trial participants.
  • Deputise for other members of the Project Management team during absences.


SKILLS REQUIRED

ESSENTIAL
  • BSc within a Life Science or overseas equivalent
  • Knowledge of the basic principles of project management
  • Experience in building effective working relationships
  • Familiar with Microsoft Office, including Word and Excel.
  • Excellent organisation and time management skills
  • Able to write well-constructed, grammatically correct text
  • High level of attention to detail and standards
  • Ability to respond to client requests in a precise and timely manner
  • Ability to work to deadlines with changing priorities
  • Ability to work effectively within a team
  • Logical and analytical thinker


DESIRABLE
  • Previous experience of working within Clinical Research
  • Awareness of Good Clinical Practice
  • Organisational skills to manage multiple projects


WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.

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