Simbec Orion Group Ltd
London, Greater London, United Kingdom
Job type: fulltime
Job industry: Science & Technology
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 your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.
* Main Duties and Responsibilities: *
We are looking for a Project Manager to join our Project Management Clinical Pharmacology. You will be based remotely in the UK.
You will be responsible for planning and management of Clinical Pharmacology trials at Simbec-Orion, including advising on trial design and methodology. You will act as the key contact for internal and external stakeholders and will prepare key trial documents, such as protocols, patient information leaflets, and regulatory applications. You will ensure that clinical trials are conducted on time, on budget, according to SOPs, ICH- GCP and local regulations, in accordance with high-quality standards and contract specifications.
* Manage projects in accordance with Good Clinical Practice (ICH-GCP), 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.
* Advise on projects with clients, internal stakeholders and sub-contractors (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.
* Ensure that appropriate resources are allocated at the appropriate times to ensure projects are delivered on schedule and within budget and keep all stakeholders informed of Project Progress.
* Ensure that all internal and external stakeholders are informed of the project progress , escalating any issues where necessary.
* Prepare scientific and study documentation, including protocols (and subsequent amendments) and risk management plans.
* Act as a Line Manager providing guidance, coaching and mentoring to support the team's development.
* Support in Commercial Development activities such as proposal development, review of budgets and Bid Defence meetings.
* Represent the Project Management department at internal and external meetings and deputise when required.
* D eputise for other members of the Project Management team during absences.
* Minimum Requirements: *
* Essential: *
* BSc within a Life Science or overseas equivalent
* Previous experience of working within Project Management within Clinical Research
* Previous experience as a coach/mentor to other employees
* Excellent organisation and time management skills with the ability to effectively manage any changes to priorities/deadlines.
* Excellent communication and negotiation skills with the ability to influence and communicate cross-functionally across all levels of seniority
* Ability to effectively lead a project team
* Logical and analytical thinker with good problem-solving skills.
* Experience in identifying, mitigating and managing project risks.
* English Language - fluent, written & spoken
* Desirable: *
* MSc or PhD in related discipline
* Formal project management qualification/certification
* Previous experience in Phase I trials
* Previous Line management experience
* 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. *