Sr Trusted Process Specialist

INC Research UK Limited
02 Dec 2017
05 Jan 2018
Contract Type
Full Time
We are currently looking to strengthen this unique team in Camberley and are seeking Trusted Process Specialist.


Provides Subject Matter Expert (SME) assistance and expertise to support a wide-range of activities for projects (from single service studies to full scope or multiple protocol programs) as they progress through the Trusted Process. Beginning at study start-up and continuing through to project close-out and archival, this role supports the core project team relating to all elements of the Trusted Process. Actively participates in delivering results that meet the Customer's expectations, goals and timelines.

Essential Functions:

1. Assists the project team by:
* Effectively promoting teamwork;
* Training team members in use of company tools, templates, Standard Operating Procedures (SOPs), Work Instructions (WIs) and other;
* Understands group norms and dynamics, removing assumptions and adapting to different cultures and organizations;
* Developing project plans, deliverables and schedules to meet scope of work; and
* Supporting essential team communication.

2. Provides coaching and user support in the use of the following tools and processes:
* ProjectPoint implementation, support, and maintenance. Works with Project staff to maintain collaborative workspaces for individual projects;
* Clinical Trial Management System (CTMS) implementation, support, and maintenance. Works with operations staff to create, maintain, and administer projects in CTMS;
* Company standard forms and templates;
* Shipping systems; and
* Internal processes and procedures.

3. Augments core team by performing project work, promoting team compliance with appropriate procedural documents, adopting best practices from other studies, and coaching project team members throughout the project lifecycle.

4. Assists in ensuring that contracted services and expectations of a project are carried out by the project team in accordance with the executed contract and the Customer's established expectations. Duties may include liaising with Customer, vendors and/or Investigative sites.

5. Creates and facilitates group and one-on-one intermediate and advanced user training, user support, and application testing on relevant technology applications and processes.

6. Maintains effective communication within the organization through oral and written correspondence including status reports and ensures adequate documentation of communication. May be required to present required information at meetings.

7. Provides assistance and leadership on projects which may include training, system enhancements, development, improvement and documentation of processes, testing, and participation and support of validation activities.

8. Assists in managing arrangements of internal/external conferences, particularly independent management of key portions of programs. Manages program evaluation surveys, question and answer from participants and provides assistance on-site. Creates meetings reports using web-based meeting tools.

9. Alerts senior management to potential issues.

10. Serves as resource to produce deliverables for study start up, maintenance and close-out. Using expert knowledge of SOPs and WIs, reviews work products throughout the process to identify deviations and/or quality concerns. Works closely with project team members during all phases of the Trusted Process to ensure internal compliance.

11. Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned Project Manager (PM). Assesses and communicates KPIs for associated job tasks to PM with proposed action plan.

12. May lead small projects, communicating project status and key timelines to appropriate associates.



B.A./B.S. in the life sciences, nursing degree, or equivalent combination of education and experience. Nominal clinical research experience. Prior experience in a contract research organization, pharmaceutical, or biotechnology company is preferred. Clinical Research Organization and relevant therapeutic experience is preferred. Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment are essential. Presentation, documentation and interpersonal skills as well as a team-oriented approach. Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary; basic computer skills using MS Project are preferred. Must have valid, current driver's license and ability to secure corporate credit card.


Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.