Founded in 2006, MRN is an innovative, market-leading, global provider of community-based trials and site nurse support solutions for the clinical trials industry.
About the role…
The Project Manager will lead and deliver complex home trial projects on time and within budget, and in accordance with international laws and guidelines.
Key responsibilities include:
- Being part of study team to include, Operations, Nursing, Vendor Contracts Management Team, Proposals, Contracts, Pharmacy and Quality staff to plan, manage, track and monitor projects to ensure they are delivered on time and within budget, in compliance with MRN procedures and applicable regulations
- Supported by the Project Management Office provide accurate and timely information to the Project Management Group Head, Project Director, Project Management, clients and sponsors on overall project performance including both financial and operational aspects
- Undertake activities as described below and participate in specific activities as defined in MRN RACI or appropriate study delivery plan/ study activities
- Create and implement individual plan(s) for assigned project(s), as applicable, to include an assessment of potential risks to the project delivery and a contingency plan. Use tools such as MS-Project and the service detail specification Manage and participate in internal and external kick off meetings, with understanding of study objectives and customer requirements
- Drive cross-functional project activities, as appropriate in the study delivery plan
- Accountability/ oversight in the creation and production of study documents. e.g. VRF, SRF, POF by the appropriate functions/ personnel
- In association with Vendor Contracts, Portfolio Management Office, Visit Management and other Project Management personnel drive set up of MRN corporate systems and tools. e.g. (not limited to) MsP, SMART, TEC, study tracking Project Plan spreadsheet
- Lead, attend sponsor/client meetings as required; support Project Director, minute meetings
- In association with Vendor Management, and Visit Management, define and procure required supplies and equipment for the study, per budget.
- Drive study forecasting and budget management on assigned studies
Recruitment / Ongoing studies
- Use study metrics to track and report activities, risks internally and externally (including governance meetings)
- Use operational metrics information to ensure accurate monthly billing to clients/customers
- Oversee HcP onboarding and visit readiness status in coordination with visit management and nursing (study training) team
- Ensure study visits take place as scheduled, minimizing missed/ failed visits due to MRN influenced factors
- Work with study team to anticipate issues and resolve in a timely manner. Track issues on study log and ensure appropriate dissemination of information to relevant departments
- Ensure study team compliance in appropriate and timely filing of study documents and emails
- Monitor and track study income and expenditure to ensure agreed project margins are maintained
- Liaise with Vendor Management, Proposals and Contracts departments to revise study requirements in line with client/sponsor requests resulting from study process and protocol amendments
- Study team develop positive relationships with clients, sponsors, vendors and sites
- Ensure all equipment is returned/accounted and other study material destroyed
- Study close-out and archiving according to MRN and any sponsor specific requirements
- Ensure finances are reconciled and final invoices are generated and presented for payment in a timely manner
General/ Additional Responsibilities
- Timely issue management, escalation and communication, per process, on assigned studies
- Participate in internal/external audits and external inspections as required, manage study specific aspects of CAPA arising from audits/inspections
- Participate in MRN non study project groups to deliver continuous improvement
- Organise, chair and participate in internal and client/sponsor meetings, responsible for meeting minutes and their timely distribution
Skills, Experience, and Qualifications…
We are looking for talented individuals who have working knowledge of ICH GCP and appropriate regulatory laws and guidelines. Individuals who have the ability to multi-task, problem solve and priorities a complex workload is a must.
It’s Essential you have:
- Strong project management experience with either a Sponsor or CRO (clinical research organisation)
- Proven effectiveness in leading a cross functional teams
- Experience in planning and delivering projects on time and to budget
- Knowledge of financial management and be able to demonstrate commercial awareness
- Able to present both a top line overview and in-depth detail of projects as required
Where: Milton Keynes (Hybrid working options available)
Contract type: This is a full-time, permanent position
MRN are proud to be an equal opportunity employer
We are an equal opportunity employer who values diversity. Our aim is to work simultaneously to promote a more inclusive and safer environment for everyone, which attracts all candidates and portrays our commitment to celebrate and promote diversity.
DBS Disclosure may be requested in the event of being offered the position. Having a criminal record will not necessarily prevent you from working with us. This will depend on the nature of the position and the circumstances and background of the offence(s).