Associate Project Manager

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Job description

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 - Clinical Pharmacology department in Merthyr Tydfil. You can be based remotely in the UK with an expectation that you'll travel to the offices on a regular basis.

You assist the Project Managers within Clinical Pharmacology in the design, execution and delivery of clinical trials ("projects"), ensuring that projects are conducted in accordance with the regulations and latest guidelines, and internal stakeholder and client's clinical development needs.

*Key Accountabilities:*

* Assist in the conduct and management of all projects to the standards of Good Clinical Practice (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.
* Take part in discussion with clients and sub-contractors, regarding the project (including study design, feasibility, budgets and timeframes)
* Maintain an awareness of current guidelines and advances in clinical research to support such discussion.
* 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 or oversee 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).
* Prepare or assist with generation of study documents and perform departmental QC duties.
* Assist when necessary with clinical procedures such a dosing of trial participants.
* Deputise for Project Managers and other members of staff during absence.

*Minimum Requirements:*

*Essential:*

* BSc in Life Science
* Knowledge of the basic principles of project management
* Experience of building effective working relationships
* Familiar with Microsoft Office including Word and Excel
* Excellent organization 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

Simbec-Orion Job Profile - Associate Project Manager - Clin Pharm.pdf

* 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. *