Job Title

Clinical Project Team Manager I/II (Berkshire)

Salary

£30,000 - £45,999, £46,000 - £59,999

Job Type

Clinical Study Management/Operations, Clinical Project/Program Management, CRA Management, GCP Training, Project Control & Budgets

Location

Berkshire/Buckinghamshire

Employment Type

Permanent Job

Employer Type

CRO Full Service

Seniority

Team Manager/Project Manager

Duration

 

FTE Hours

Full Time 35 - 40hrs Per Wk

Vacancy Status

Open For Applications

Date Posted

Mon 14th July 2008, 03:30pm

Permanent roles with a World Class CRO working office or field based in the Berkshire office. Posts open at CPM I - III level. A chance to secure people management and project delivery competence on a global basis with a company focused on quality and people development. Key attributes you should display to apply are: At least 2yrs experience as CPM for a pharma or CRO managing clinical trials in Phase II or III, International CPM experience, managing teams including members outside UK e.g. EU,ROW or US
Therapeutic experience experience in Rheumatoid Arthritis, Oncology, Phase I would be ideal but not essential. Finally the ability to directly manager CRAs in teams without functional line management.

Role:

Manage the activities oflarge multinational studies and project teams in a manner that ensures all timeframes and targets are met and that costs are kept under control.
To effectively manage assigned staff to ensure high performance, continuous development and low turnover.
To provide expert clinical operations input into new business proposals and bid defence meetings.
Manage projects in a timely manner in adherence with SOPs, ICH GCP and appropriate regulations and liaise with other department managers as necessaryto achieve this.
Develop and maintain a detailed Project Plan for assigned projects.
Manage projects in accordance with the contract. Pro-actively recognise any changes in scope and collaborate with Business Development (BD) to ensure timely completion of change orders.
Effectively manage the study budget to ensure financial targets are met through regular review of indirect costs and project resources. Collaborate with Finance to ensure accurate revenue recognition.
Implement QC procedures^and monitor quality metrics to ensure a high quality standard is maintained throughout the project.
Act as the key client contact for designated projects and develop successful working relationships with clients to help secure repeat business.
Ensure all necessary training is provided to his/her staff to improve their job performance and knowledge. Provide coaching/mentoring, as necessary. Implement individual development plans and ensure training is documented, as appropriate.
Effectively^manage staff through open and timely sharing of information, regular performance review and feedback, and setting clear goals and objectives. Ensure individual and team achievements are appropriately recognized.
Develop a succession plan and, inthe event of team changes, ensure a thorough and effective handover which is appropriately documented.
Ensure time management system is up to date and monitor workload for assigned ClinicalResearch Associates (CRAs). Pro-actively flag potential resource issues to Director of Clinical Operations/Regional Director/Associate Director Clinical Operations.
Provide regular feedback to senior management on project status, client satisfaction and staff issues.
Participate in interviews, as required.
Mentor other Clinical Project Managers (CPMs)/Associate Clinical Project Managers and contribute to department training initiatives, as appropriate.
Provide expert clinical operations input into new business proposals and bid defence meetings.
Actively participate in or lead process improvement initiatives.
Maintain confidentiality of management information, as appropriate.
Participate in business development activities, as appropriate.
Participate in the Out of Hours on-call pager rota, as required.


QUALIFICATIONS/EXPERIENCE REQUIRED:

Background in medicine, science or other relevant discipline and proven track record in managing large multinational studies and project teams, with broad therapeutic area experience.
Significant experience in clinical research, with competence as a project manager.
Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
In depth understanding of project management processes and drug development.
Highly developed problem-solving skills.
Strong people management skills.
Effective communicator.
Good commercial awareness and customer focus.
Fluent in written and spoken English. Additional language skills desirable.
Computer literate.
Current full driving licence.
Ability and willingness to travel at least 25% of the time (international and domestic; fly and drive).