Clinical Project Manager

OVERVIEW:

To deliver company projects on time and within budget, and in accordance with international laws and guidelines. Maintain and enhance internal and external relationships with operational and commercial focus

KEY ACCOUNTABILITIES:

Part of study team to include, Operations, nursing, VCMT, proposals and contracts (P&C), Pharmacy and Quality staff to plan, manage and monitor projects to ensure they are delivered on time and within budget.
Supported by the PMO provide accurate and timely information to the PMGH, PMDir, clients and sponsors on overall project performance including both financial and operational aspects.
Under take activities as described below and participate in specific activities as defined in company project summary.

Additional responsibilities include:

Start up

Create a plan for each project for all individual projects to include an assessment of potential risks to the project delivery and a contingency plan. Use tools such as GANTT charts and he service detail check list.
Manage and participate in internal and external kick off meetings, with under standing of study objectives and customer requirements
Plan nurse training and execution of support documents in association with the Nurse Manager
Responsible for the creation and production of site support documents. e.g. VRF, SRF, POF supported by the PSA.
In association with VCMT, PMO, PSA and PA set up corporate systems and tools .e.g SMART, TEC, study tracking Project Plan spreadsheet
Attend sponsor/client meetings as required, minute meetings.
In association with VCMT, and PSA/PA define and procure required for the study.

Recruitment/ Ongoing studies

Use study metrics to track and report activities internally and externally
Use operational metrics information to ensure accurate monthly billing to clients/customers
Liaise with nursing team to engage suitable nurses to under take visits
Ensure study visits take place as scheduled, minimising missed visits due to company 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.
With PSA/PA ensure study documents and emails are filed appropriately
Be aware of study income and expenditure to ensure agreed project margins are maintained.
Liaise with VCMT and P&C 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

Study completion

Ensure all equipment is returned/accounted and other study material destroyed.
Study archiving according to company and any the sponsor specific requirements
Final invoices are generated and presented for payment in a timely manner

General

Participate in internal/external audits and external inspections as required, manage study specific aspects of CAPA arising from audits/inspections
Participate in company 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 REQUIRED:

Qualifications

Degree level education, or nursing equivalent, science/medical based subjects preferred

Experience

Minimum 3 years (4–5 years desirable) relevant experience to include sponsor/CRO, and or site clinical research experience
Proven effectiveness in leading a cross functional teams
Proven experience in planning and delivering projects on time and to budget

Technical Skills & attributes

Working knowledge of ICH GCP and appropriate regulatory laws and guidelines
Understanding of project financial management
Ability to multi task, problem solve and prioritise complex workload
Computer literate –intermediate skills in MS office Excel, Word, Outlook, and company systems

Personal attributes

Professional and customer focused with positive outlook
Flexible with 'Can do' attitude able to supervise and direct others but also under take hands on tasks when required
Able to work with and present top line overview and in depth detail of projects
Self driven with respect to professional development, and continuing education
Able to acquire basic skills/knowledge from expert departments e.g. nursing, VCMT, pharmacy to allow them to participate in teams as advisors as well as providers
The ability to define and document process
Ability to work independently and as part of a team

Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.