Study Start up Specialist II, Ethics Submission office based, Munich
Do you know Covance is one of world´s leading Contract Research Organization?
For example, our Clinical Development teams have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.
The work we do at Covance impacts the lives of millions of people around the world… so could you too as our next:
• Start-up Specialist, full-time, office based in Munich. We look for someone with background in Ethics Committees Submissions and / or Site Contract negotiations.
Can you bring your drive to our cutting-edge clinical projects?
If you chose the Submissions path, you will work with investigative sites to collect the required investigator and regulatory documents to perform clinical trials in the DACH region, and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations and/or the study sponsor.
If you chose the Contract path, you will negotiate contracts with the Investigators and clinical sites involved in clinical trials.
Act as the lead contact with investigative sites during assigned site start-up activities
Oversee timely collection of the required investigator and regulatory documents for a study as specified by regulatory authorities and sponsor.
Ensure the ongoing accuracy and quality of site/study documents.
Ensure high quality documents are filed in (e)TMF and systems are updated on an ongoing basis ensuring Covance is audit ready at any time.
When applicable, work with staff in Business Development and Operations, to provide relevant input critical to successful trial execution.
Provide accurate projections and timelines to study teams based upon country’s historical performance and agreed with Sponsor.
Ensure project plans are followed for the Site Activation component of assigned studies, proactively engaging with key stakeholders to assure milestones are adequately represented and are being achieved and driving for solutions.
Participate in team meetings to report progress and challenges in trials. Identify potential risks to timelines and results and manage issues independently.
Review and customize country and site specific patient informed consents for compliance with local requirements and protocol.
Proactively resolve informed consent issues and other potential difficulties with study sites.
Monitor start up activities to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.
May negotiate contracts and budgets with investigative sites within parameters provided by SU PM and Sponsor.
Liaise with Covance Regulatory department regarding document submission requirements, if applicable.
When needed review data for feasibility assessments at a country level.
Coach less experienced study team members as appropriate.
May be asked to negotiate timelines or delivery of project plan with SUPM’s under direction of senior specialist/SUCM
Perform other duties as assigned by management
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.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered
Experience in clinical development or regulatory process.
Significant experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
Significant experience of issue escalation and resolution.
Proven track record of effective communication and problem solving.
Experienced in creating and maintaining good business relationships
Proven ability to work under pressure with multiple internal clients with competing goals
Strong experience in contract and budget negotiations with clinical sites is requested. Law background preferred but not mandatory.