GLOBAL STUDY START UP ASSOCIATE / based on a client site in Paris, France
Location: Paris, France
Closing Date: 15 Mar 17
Salary (£): Competitive
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. We are currently seeing substantial growth in our study start-up team and are looking for a Global Study Start up Specialist to be based on a client site in Paris. This is a very exciting time for Covance and for the study start-up team. In this role you will have a great opportunity to progress in your career and develop.
About the job:
Responsibilities assigned by the client within the Finance team include:
- - Payment of invoices
- - Manage and negotiate contracts with investigators and hospitals with the respect of deadlines
- - Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
- - Train and mentor Clinical Project Administrators
- - Assist with coordinating vendors
- - Organize/prepare for client meetings/teleconferences
- - Assist/prepare for client or internal audits
- - Develop project specific plans for the GSS component of assigned studies
- - Liaise with operational project team regarding project issues (i.e., participate in team meetings)
- - Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
- - Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
- - Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
- - Review and approve investigative site specific patient informed consents for required elements
- - Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
- - Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
- - Liaise with Sponsor and Covance regulatory regarding document submission requirements
- - Maintain and update document tracking, site address and contact information in the Site Information
- - Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
- - Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly
- - Prepare new investigator submission packages to Local and/ ot Central IRB /IEC
- - Attend ongoing training in GCP, project specific requirements and as may generally be required
- - Provide milestone information for incorporation into weekly analysis sheets
- - Monitor performance of GSS team with regard to project timelines
- - Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
- - Understand and follow project specific and GSS policies and procedures
- - Assume responsibility for the preparation and dissemination of documents according to the feasibility processes in place
- - Create surveys to probe “thought leaders” and Experience d researchers and clinicians in the field for expert feedback
- - Assist with preparation of materials for formal client/industry presentations and for internal training assignments
- - Apply basic understanding of data spreadsheets and tables
- - Assist with entering data into spreadsheets when required
- - Review and audit data tables and spreadsheets for feasibility assessments
- - Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals
- - Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study Experience , and Investigator self-reported data
- - Undertake literature and internet searches as required
- - Mentor other GSS team members
- - Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles
- - Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate
- - Perform other duties as assigned by management
- - Ideally, you will have a Life Science degree and at least 2 years of relevant work Experience in study start-up
- - Aptitude for tracking and proofreading contracts, with an understanding of contract lifecycle
- - Exceptional oral and written communication skills
- - Computer/database literacy
- - Able to keep calm under pressure, capable of multi-tasking, able to priorities work load
- - Have an eye for detail
- - Able to deal with all levels of people and forge strong working relationships with both
- internal and external customers
- - Good oral and written communication skills, both French and English
Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality.
We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Please submit CVs and cover notes in English
Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.