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Project Director - UK

Employer
Simbec-Orion
Location
Homeworking, United Kingdom
Salary
Competitive
Start date
25 Oct 2021
Closing date
20 Nov 2021

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Discipline
Clinical Research, Clinical Project Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

Job Details

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 a Project Director to join our Project Management - Clinical Pharmacology department.

You will provide leadership in managing multiple Clinical Pharmacology trials at Simbec-Orion. You will coordinate all trial activities across functional departments and vendors according to the Contract and scope of work and will be accountable for the successful management and completion of assigned clinical trials. You will serve as the primary contact for the Sponsors to ensure that the study conduct and completion are progressing according to the Sponsors needs and expectations.

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. You will participate in Project Management and company-wide initiatives supporting the development of the project management function within Simbec-Orion. You will lead and manage a team, providing coaching and mentoring and monitoring the team's workload.

Key Accountabilities:
  • Lead 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) acting as a Subject Matter Expert.
  • 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.
  • 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.
  • Lead on 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.
  • Lead on the generation of new SOPs and processes across the department.
  • Deputise 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 line manager
  • Previous experience of deputising for Senior members of the team
  • 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 lead and communicate cross-functionally across all levels of seniority
  • Proven track record of leading 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 experience in business development activities, i.e., bid-defence meetings and proposal and budget reviews


Simbec-Orion Job Profile - Project Director - 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.

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