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Job Details

Project Manager - Clinical Development Services (United Kingdom)

Company: INC Research
Location: Lewes
Reference: 17001350
Closing Date: 16 Mar 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

We are looking for an experienced Project Manager with a proven track record of delivering multi service projects and who has a strong interest in Clinical Development Services and ready for the next step in your development.

Requirements:

Here at INC we have an exciting new opportunity for a Clinical Development Services(CDS)Project Manager to join our growing global team. This is a full oversight and leadership project management position allowing a flexible and dynamic interface with our clients and our own CDS project teams. The beauty of this role is in the variety of the projects you will be working on– CDS is group encompassing departments of Biometrics (Data Management, Biostatistics & Medical Writing) , Early Phase, Devices, Late Phase, Site Start Up, Safety & PVG. It could be a multiple aspect Biometrics project, a Preferred Provider relationship, global regulatory submission data package.

We are looking for an experienced Project Manager with a proven track record of delivering multi service projects and who has a strong interest in Clinical Development Services and ready for the next step in your development.

Where you work– we can offer multiple options and look forward to hearing on how you can demonstrate success in this role.

Responsibilities:

Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations.  Works in the role of a project manager on assigned project(s), which may range from single CDS  (e.g. Biostatistics) projects to large full scope CDS projects.  Duties include primary liaison with Customers, Functional leads, and Senior Management.

Essential Functions:

1.     Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement.  Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.

2.     Serves as the team leader by overseeing the CDS project team.  Facilitates team building and communication.   Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues.  Proactively montiors project resources and works with  functional lead/management to ensure  match  requirments across all areas for projects.

3.     Manages multiple projects ranging in size and complexity from single service CDS projects to large full scope CDS projects, global projects and/or programs, with minimal interaction from supervisor.  This includes proactive operational and financial management of tasks, risk, escalations and quality through to project delivery.

4.     Manages the executed contract and financial aspects of assigned projects/programs as needed.  Ensures customers are invoiced in a timely manner and follows up on receipt of payment as needed.                                 

5.     Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication.                                                       

6.     Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery. 

7.     Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.  Produces and distributes status and tracking reports as well as functional area plan to appropriate team members and senior management.

8.     Networks to acquire new and/or repeat business.

9.     Supports the Business Development Department by providing information on the Company CDS capabilities.  Presents Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.

10.  Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities as needed.  Works with this team and departmenmtal leads to develop budgets and scope of work for the final contract as needed.

Other Responsibilities:

 

1.     Represents the Company at professional meetings or seminars.

2.     May develop and refine project management processes within the Company.

3.     Performs other work-related duties as assigned.

4.     May develop and/or review SOPs and WIs related to any area concerning CDS project management.

5.     May develop and refine processes within the Company which lead to greater efficiencies or competitive advantages over other companies.

6.     Minimal travel may be required (up to 25%).

Qualifications

Requirements: 
BA/BS in life sciences, communications, nursing, or equivalent related education and experience.  Project management experience in a contract research organization, pharmaceutical, or biotechnology company.   Experience actively managing clinical research projects across CDS functional areas.   Previous CRO experience and specific CDS management experience.   Other relevant experience preferred.  Thorough knowledge of major HA (e.g. FDA, EMEA, PMDA) regulations, drug development, and project management procedures.   Demonstrated proficiency with ICH/GCP guidelines.  Strong presentation, documentation, and interpersonal (emphasis on proactive leadership) skills as well as a team-oriented approach.   Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet.  Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
 

Apply for this job: Project Manager - Clinical Development Services (United Kingdom)

Contact Information:

Address:  European Head Office
River View, The Meadows Business Park,
Station Approach,
Blackwater,
Surrey
GU17 9AB
England
Tel:  +44 (0) 1189 335 300
Website:  Visit Our Web Site

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