ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
The Associate Director Clinical Trials (ADCT) is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with the heading of a project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
- Proven success in the oversight and delivery of outsourced clinical trial deliverables
- Support in preparation of regular status reports to SDCO and ADCT / Chief Medical Officer (CMO), including presentation of project status in meetings
- Overlooking the clinical operation trial budget
- Opportune contact with PM and ADCO in case of divergences from the project plan
- Oversight on project timelines and deliverables
- Set-up or oversight of study related documents such like Study Management Plan, Monitor Manual, etc.
- Contribution to and review of study core documents, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
- Supervision/ quality control of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training
- Co-ordination of project activities with other sponsor departments
- Instruction and supervision of CTCs, CRAs and CTAs (in the scope of a project)
- Point of contact in case of problems within the clinical trial
- Support in planning and conduct of project training prior to starting project activities, oversight if project team has appropriate trainings and report training needs to the ADCO
- Organization and conduct of study team meetings
- Review of all clinical trial activities from start-up to close out
- Responsibility for oversight of the Trial Master File (paper or electronic) during the clinical trial and initiation or performance of regular QC checks
- Processing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelines
- Support in the process of selection and decision on participation of investigator sites
- Organization and participation in investigator meetings
- Oversight and handling of contract negotiations with trial sites/ pharmacies/ local labs in Germany, correspondence with legal.
- Co-monitoring if planned in the scope of a project
- Support of internal or site audits and/or hosting inspections in the scope of a project
- Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)
You are:
- Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
- Minimum 7 years of experience in trial leadership, project management, regulatory submissions and global study organizations
- Refined colloquial and correspondence (written and spoken)
- Very good English (written and spoken)
- Experience in usual software (Word, Excel, Power Point, MS Project)
- Ready to take over responsibility
- Able to rapidly enter in action and to work under stress conditions
- Used to work in a team and lead a project team
- Used to work, lead and coordinate external vendors and external teams
- Able to recognize problems and provide solutions
- Excellent organizational skills
- Excellent communicative skills
- Independent and pro-active way of working
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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