Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.
Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!
If you are looking to take on responsibility and leverage your know-how in the start-up phase of clinical trials - ensuring a successful start of important clinical studies in Germany-, this is the perfect opportunity.
You will be working alongside our dedicated and supportive team of SSU experts in a role that allows you to have a real impact on people’s health and lives.
What we have to offer?
a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.
Your responsibilities :
- Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and applicable laws and guidelines
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.
- Participate in team meetings to progress trials and identify site issues that might impact the timelines.
- When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol.
- Proactively resolve informed consent issues and other potential difficulties with study sites.
- Liaise with Labcorp Regulatory department regarding document submission requirements, if applicable.
- Prepare submissions to IRB / IEC, and regulatory authorities; Liaise with applicable IRB / IEC and / or regulatory authorities (if applicable) regarding submission / approval issues.
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
- May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones / developments, intervening and escalating as appropriate.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements.
- Perform other duties as assigned by management.
Does this role sound appealing to you? Then apply today! Labcorp offers excellent working conditions as well as competitive benefits.
We look forward to hearing from you and to discuss further this employment opportunity
Labcorp is proud to be an Equal Opportunity Employer :
- As an EOE / AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
- We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions / needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
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