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Head of Early Phase Unit

4 months ago

Manchester, United Kingdom MAC Clinical Research Full time

MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.

We are now seeking to appoint a Head of Early Phase Unit to join our dedicated team at our Manchester clinic.

**FOCUS OF THE JOB**:
Responsible for overseeing the departmental performance in meeting the needs of Sponsors to provide safe and efficient delivery of studies. Working with the unit teams and medical leads to create and maintain a culture of clinical excellence, process improvement, effective leadership and high standards of volunteer/ patient care.

**KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED**:

- A minimum of 4 years’ experience working within a Senior Strategic Management role, along with a good understanding of Clinical Operations.
- A minimum of 7 years’ experience within the field of clinical trials, Early Phase preferred, or relevant clinical setting
- RGN / RMN or BSc Nursing / Biomedical or BSc in a scientific field would be highly desirable

**RESPONSIBILITIES**:

- Departmental operational oversight of business activities at the Early Phase Unit in accordance with ICH-GCP, MHRA Phase 1 Accreditation, MAC SOPs and Study specific protocols whilst optimising profitability by leading the MAC teams to meet/exceed business projections.
- Lead MAC’s Early Phase unit - supporting to optimise process and best in class activities to preserve quality and patient safety.
- Ensure the clinical unit is working to highest standards of quality.
- Takes a primary role for planning and organising service provision and clinical strategies.
- Contributes to the acceleration of startup times and FPFVs.
- Takes a lead in service development and process improvement.
- Works with Business Development to support business growth and expansion.
- Work with Senior Management and team Leads to drive and exceed business objectives and KPI’s.
- Brings issues to the attention of the relevant operational members and managers to facilitate the smooth running of the clinical functions and escalate appropriately to higher senior management levels.
- Works with Proposals and Feasibility to assess proposed study feasibility and capacity.
- Consult, advise, coordinate, and implement various aspects of stakeholder engagement and communication efforts.
- Always maintain a professional attitude and appearance to customers/colleagues.
- Compliance with MAC health and Safety policy
- Compliance with MAC policy on equality and diversity
- To maintain professional qualifications required for the role, including continuous personal development.
- To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
- To work according to MAC SOPs, guidelines and policies
- To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.

**BENEFITS**:

- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
- Health Insurance
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years' service)
- Your birthday off work

**Benefits**:

- Company pension
- Free parking
- On-site parking
- Private medical insurance

Ability to commute/relocate:

- Manchester: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Will you require sponsorship to work in the UK (now or in the future)?

**Experience**:

- Senior Strategic Management: 4 years (required)
- Clinical trials/Clinical Research: 7 years (required)

Work authorisation:

- United Kingdom (required)

Work Location: In person