A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
- Support CTLs/ Trial Teams / COT for budget management, trial medication activities, special activities for vendor surveillance, budget forecast, surveillance of company compliance in trials/programs and building accruals as appropriate.
- Knowledge and usage of databases and programs of the department.
- Proficient in using financial tools / systems to create accurate financial documents.
- Responsible for invoice processing and tracking in a timely manner.
- Ensure that all financial documentation is audit readily for inspection at all time.
- Review the Clinical Trial Management System (e.g. SWAN, Infosario) for any relevant details required. Ensure in conjunction with the CTL that all systems are updated on a regular basis.
- Perform TMF vendor surveillance as appropriate. Communicate with CRO or other functions accordingly to ensure TMF inspection readiness at all time (under CTL responsibility).
- Prepare and coordinate the process for the creation of legal documents for clinical trials/programs, e.g. Power of Attorney.
- Ensure together with CTLs/ Trial Teams / COT that risk management for the corresponding trials / programs is established and updated on an ongoing basis together with the CRO.
- Contribute to workshops / special initiatives as expert / professional for dedicated topics.
- Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as required.
- Develop and maintain complex administrative systems / reports and formats.
- Ensure all trackers are maintained in an up to date manner and available for the CTLs/ Trial Teams / COT to consult.
- Support CTLs for Investigator Meetings, as applicable. Ensure that correct code of practice / compliance is adhered to by the CRO and relevant information is provided to assist this process.
- Organize meetings that are not under the responsibility of the CRO, as required.
- Assist in the development of and/or delivery of presentations, as requested.
- In conjunction with the CRO, establish and maintain archiving according to ICH-GCP, company SOPs and WIs, as requested.
- Assist the CTLs/ Trial Teams / COT in preparation of Audits or Inspections and participate in audit and inspection interviews, as required.
- Assist in the set-up and follow-up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requested.
- Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge.
- Take on additional tasks as assigned by management.
Who you are
- Secondary education with commercial or secretarial diploma(s) (or local equivalent) or higher degree.
- Preferably science degree or biomedical degree.
- Good oral and written communication in English.
PROFESSIONAL SKILLS & EXPERIENCE
- Preferably 1-2 years working experience in a clinical research-related position.
- Strong computer skills including knowledge of MS Office ™ (Excel™, Word™, PowerPoint™) and Lotus Notes™. Database skills is an advantage.
- Ability to work with computer applications.
- Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP.
- Good knowledge of medical terminology (and therapeutic areas).
- Familiar with the responsibilities and needs of other functions in a clinical trial.
- Experience working in a high-volume environment handling multiple tasks.
- Strong administrative skills.
- Preferable experience in risk management and audit / inspection readiness preparation.
- Communication skills including working processes in English as the main business language, preferably experience in clinical trial management terminology.
PERSONAL SKILLS & COMPETENCIES
- Good time and priority management skill, ability to work efficiently under pressure.
- Reliable, conscientious and confidential.
- Self-motivated, shows initiative, is proactive and able to work independently as well as in a team.
- Good communication skills – both verbal and written.
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
- Good organizational and problem-solving skills.
- Willing to take on responsibility.
- Ability to work in an international/ multicultural matrix environment.
Function area: Global Research & Development
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com