Head of Early Phase Unit - Greater Manchester, United Kingdom - MAC Clinical Research

Description

Job Description

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

FOCUS OF THE JOB:

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.

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:

• RGN / RMN or BSc Nursing / Biomedical or BSc in a scientific field / relevant clinical trial experience
• A minimum of 7 years' experience within the field of clinical trials, Early Phase preferred, or relevant clinical setting
• A minimum of 4 years' prior leadership experience

RESPONSIBILITIES (including staff):

• 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.
• Define and remain current with responsible department goals and overall expectations, increasing team knowledge and skills.
• Works with operational managers to lead, retain and develop staff.
• 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.
• To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.
• To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers.

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:

• Potentially long periods standing.
• Long periods looking at a computer screen.
• Meeting deadlines and working within strict timelines.
• Flexible approach to working hours with a requirement to work some unsocial hours to meet the needs of the clinical unit.
• Ability to travel between sites if required.
• Ability to travel to national / international meetings.

BENEFITS:

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

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

Please email should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.