Electronic Data Capture (EDC) Manager

Chiltern International is a well established global contract research organization with offices throughout Europe, North America and India.  We were established in 1982 and have served pharmaceutical, biotechnology, and device companies in over 38 countries worldwide.  Due to our continued growth, Chiltern is seeking a highly motivated individual to join us as a EDC Manager.  Candidates can be located anywhere in Philadelphia, PA.

 

 

The qualified candidate will:

· Experience in a clinical development environment

· Experience in, or knowledge and understanding of, EDC

· Experience in business process re-engineering or implementation planning

· Experience in bids development and bid defense presentations

· Experience in proposal writing for EDC specific tasks

· Project planning or project management skills including project finances

· Multi-lingual skills a plus

· Proven communication skills

 

Essential job functions include: 

· Manage a team of EDC TPLs or Technical Trainers as allocated. Responsibility for all aspects of this team as detailed below:

o  Staff reviews.

o  Approval of all monthly reports and expenses

o  Approval of all sick leave and holiday leave

o  Approval of weekly timesheets

o  Supervision of the computer requirements

o  Ensuring that all technical support is handled appropriately

o  Recruitment of new EDC Solutions staff

o  Mentoring of all EDC Solutions staff in order to better the resources and the team

· Pro-actively communicate with the Chiltern Project team and eTechnology vendors in order to meet /exceed sponsor requirements.  Take action where required in order to meet the timelines and deliverables.

· Work with the study teams, advising and informing on the processes that have to be completed to enable the technology to be implemented. Acting as a mentor to the teams, encouraging interest and building confidence in the systems.

· Create and document EDC budgets and proposals as required. Think outside the ordinary in order to create creative solutions for all budgets/clients.

· Organize, direct and coordinate planning and implementation of contracted activities including contribution to study newsletters, presentations at Investigator Meeting, Project Team training.

· Advise management regularly on the status and any potential risks or issues with on-going projects to ensure resolutions in a timely manner including any potential issues with resources.

· Manage study finances as appropriate for projects within the EDC Solutions team including WIPS.

· Assist Sponsors with EDC adoption and implementation tasks including Vendor Selection, Investigator site selection, and site training as required.

· Pro-actively market and sell the services of EDC Solutions including sales presentations and bid defense meetings

· Act as EDC TPL for a project, supporting the Project team, including attending relevant project meetings.

· Assist with eCRF development as needed to support other Biometrics departments.

 

 

Required skills and abilities include:

· Ability to manage multiple contacts and relationships at various levels

· Ability to take a lead position on a project

· Ability to train, particularly technical training to different levels of ability

· Self starter who is able to work independently and willing to provide original thinking

· Successful team player with good oral and written communication skills.

· Computer literate and working knowledge of MS Office 

· Pro-active approach to day to day operations

 

 

Chiltern’s unique corporate culture encourages a healthy balance of personal life and work.  We offer an excellent salary and benefit package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, paid life insurance, AD&D, long and short term disability and many other employee incentives.  If you have the experience required and feel you are the dynamic person we are looking for, please forward your resume in a Word document via email to:  uscareers@chiltern.com