COVANCE DENMARK - is recruiting for Global Site Services Specialist/ S
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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. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
We are currently recruiting for Global Site Services Specialist/ Start Up Specialist in Denmark.
About the job:
- 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) - Manage set up and maintenance of investigative site files - Understand and follow project specific and GSS policies and procedures - Manage the drug supply vendor activities as applicable - Develop, review and approve drug supply labels as applicable - Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes - 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 - Establish, conduct and maintain relevant QC processes in regards Feasibility Assessments - Conduct QC of feasibility documents as required by the process - Undertake literature and internet searches as required - Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report - Mentor other GSS team members - Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles.
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations. - Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites - Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe - Good organizational and time management skills - Excellent communication / writing skills - Strong computer skills with an ability to access and leverage technology alternatives - Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies - Self-motivation with the ability to work under pressure to meet deadlines - Works well independently as well as in a team environment - Detail and process oriented - Positive attitude and approach - Multi-tasking capability - Ability to work independently
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EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.