STUDY START-UP PROJECT MANAGER
Closing date for applications: 20 July 2022
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 Study Start-Up Project Manager to join our team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.
This role is full time and home based, with travel to other sites as required.
The focus of this role is to work with the Head of Project Management, Project Management Team and Study Team to ensure the successful set-up and delivery of stand-alone projects or programmes of work, by application of project management principles and implementation of project management methodologies and processes.
Prepare and submit IRB/IEC application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
Plan and prioritise own workload, responding efficiently to requests from multiple Project Managers.
Support the project management team with co-ordinating the study feasibility and site selection process, under direction from the Director of Project Management.
To be both a self-motivated team leader and a good team player.
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents and any updated or amended regulatory documentation.
Fulfil the role of Project Lead for 2 to 3 clinical projects in accordance with the project manager job description.
Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
Update and maintain the Trial Master File in a timely manner, ensuring the filing is accurate and inspection ready.
Work in a self-driven capacity, with limited need for oversight.
Proactively keep stakeholders informed about work progress and any issues.
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
At least 3 years’ experience of management or coordination of clinical trials, for example within a Site Management Organisation, Clinical Research Organisation, NHS clinical trials site or pharmaceutical company (or equivalent).
Knowledge of UK regulatory submissions and Trial documentation would be advantageous
Able to plan and prioritise own workload, responding efficiently to requests from multiple project managers
Excellent time management, organisation and communication skills
A life sciences degree / proven experience in the role.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve 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 note that if we receive a high volume of applications this date may be brought forwards.
Salary: Competitive + Negotiable £ Apply Now