A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
Clinical Trial Management is responsible for the strategic and tactical operational delivery and execution of R&D sponsored programs for all corporate sponsored programs for Phase I - Phase IV.
The Senior Clinical Trial Coordinator supports the Clinical Operations team in the planning, execution, management and surveillance of clinical trials and the Program Team for operational deliverables and the implementation of the clinical development strategy for a project/program.
- Supports the team to ensure high quality study budget planning, budget management, invoice processing, and oversight.
- Perform and document trial master file surveillance as well as ensure trial master file inspection readiness always by interacting with the study teams, other cross- functions as well as with the CRO. Use KPIs for Data driven oversight
- Ensure risk management for the corresponding trial / program is supported and updated on an ongoing basis
- 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
- Make process improvement suggestions and develop new process approaches; Ensure harmonization of processes throughout Global Clinical Operations
- Contribute to training and provision of direction and guidance to as well as take on mentor role to increase knowledge of new team members / new employees.
Who You Are
- Bachelor’s degree with 3 plus years of experience or Master’s degree required
- Four years of experience in a clinical research-related position preferred
- Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP
- Experience working in a high-volume environment while maintaining both organization and the ability to multitask
- Excellent administrative skills and computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™). Database skills an advantage. Ability to work with multiple computer applications
- Experience in risk management and audit / inspection readiness preparation
- Ability to supervise, mentor and coach junior staff
- Communication skills including working processes in English as the main business language, proven experience in clinical trial management terminology
- Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
- Work as highly motivated and engaged team member in a cross functional and global environment
What we offer: With us, there are always opportunities to break new ground. 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 come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.