Beschreibung
If the position of a "Clinical Operations Manager (m/f/d)" embodies your core skills, take a look at the details of our job position.Tasks and Duties
- Conduct of Phase 2a clinical study in respiratory disease indication
- Serve as a primary point of contact for all external partners involved in the clinical study; communication with partners including CRO, clinical study site, biostatistician, pharmacovigilance provider, and central and specialty laboratories
- Contract management, quotation management
- CRO oversight of the clinical study conduct and close-out activities
- Set-up and management of Trial Master File, as required for study compliance
- Support inspection readiness
- Participate in the creation of SOPs related to GCP activities, as needed
- Support regulatory submissions, e.g., clinical trial applications, protocol amendments, to Health Authorities
- Interface management to third party service providers
- Close collaboration with internal company functions e.g., Reg Affairs, CMC, QA, as needed
- Participation in monthly company project team meetings
Professional Experience
- Master's degree in life sciences or related field
- At least 5-10 years of working experience in clinical operations role
- Clinical study operations
- Biological products, e.g., monoclonal antibodies
- Knowledge of GCP guidelines and compliance
- Inspection readiness
- Excellent organizational and problem-solving skills
- Ability to work in a small team
- Capacity to work in a fast-paced environment with short timelines
- Independent, but also a team player Required capacity
- Ability to read and write in English
Further Details:
- Home-based business
- Part-time; 2 days per week
- Duration of 12 month (freelance)
If you are interest, please do not hesitate to contact me at your earliest convenience with current CV (preferably in Word Format).
If you do not have free capacities and / or this is not in line with your current career endeavor, I invite you to forward this opportunity within your network.
Thank you for your time and consideration.
Best regards,
Monika Schäffer
Candidate Consultant