COVANCE NORWAY - is looking for home based Study Start-Up Specialist I
Nr ref.: /JOBS.pl
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 seeing substantial growth in our study start-up team and are looking for a number of new colleagues. 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. You will be based in Norway working from home.
About the Job
This is an exciting opportunity to join the Study start-up team with responsibility for collection of the required investigator and regulatory documents for studies and making sure the required standard is met, this varied role will include;
- You will be the primary contact with clinical trials investigator sites during site start-up activities (i.e. site identification, selection and activation, ethics submission, setting up sites and negotiating contracts) You will manage and own ca 2-3 studies - Liaise with operational project team regarding project issues (i.e., participate in team meetings) - 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 - 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 - Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor - Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial. - Prepare core Country patient informed consents per country requirements and protocol as applicable - Prepare new investigator submission packages to Local and/ or Central IRB /IEC - 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 - Provide milestone information for incorporation into weekly analysis sheets - Manage set up and maintenance of investigative site files - 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 - Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study Experience , and Investigator self-reported data - Conduct QC of feasibility documents as required by the process - Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles
- Ideally, you will have a Life Science degree or equivalent and previous Experience of relevant work 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 - Self-motivation with the ability to work under pressure to meet deadlines - Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
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!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
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 3 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
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.