Project Manager Clinical Operations (f/m/x)
at ZEISS Group
Oberkochen, Baden-Württemberg, Germany -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Aug, 2024 | Not Specified | 27 May, 2024 | N/A | Good communication skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Your Role
- Development of study protocols in coordination with the Clinical Affairs Manager as well as with Clinical Partners
- Define test methods according to state of the art or relevant guidelines and ensure availability of required devices
- Selecting and coordinating with national and international study sites and service providers; establishing long-term clinical partnerships with international study sites
- Drafting contracts with clinical partners in coordination with the legal department including negotiation of investigator fees
- Preparation and submission of applications for approval of clinical studies to authorities and ethics committees.
- Organization and execution of clinical studies with coordination of all parties involved for planning and meeting timelines, milestones and budgets, reporting on project progress, preparing presentations to management on project/study results
- Identify and assess risks and challenges and derive appropriate preventive and corrective measures. Monitor success of measures used
- Responsibility for completeness and quality of essential study documents and appropriate archiving thereof
- Manage statistical analysis plan, statistical analysis and evaluation of clinical results analysed and preparation of study reports. Contribute to / review scientific publications, develop and define standard treatment recommendations and indication statements in collaboration with the CA manager.
- Review and evaluate new regulations, guidelines, standards for clinical studies; derive measures and adapt existing clinical affairs process descriptions
Your Profile
- Minimum four-year college/university degree in optometry/optometry, medicine, medical technology or natural sciences Work experience
- Long term experience in clinical affairs/clinical research project management in the medical device/ pharma industry or with contract research organizations
- In-depth knowledge of relevant regulatory requirements for clinical studies and clinical evaluations for medical devices (ICH-GCP, ISO 14155, MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines) and experience in planning and conducting clinical studies with proven success. Other knowledge
- Good knowledge of biostatistics, data management and regulatory requirements for CE, FDA, NMPA, Health Canada, etc. and clinical evaluations
- Demonstrated qualities in project management with external service providers/vendors, e.g., contract research organizations
- Strong analytical skills coupled with creativity and intuition
- Commitment and creative drive as well as strong communication and organizational skills in an international environment
- Very good oral and written communication in and English
- Willingness to travel worldwide
Your ZEISS Recruiting Team:
Celine Karbac
Responsibilities:
- Development of study protocols in coordination with the Clinical Affairs Manager as well as with Clinical Partners
- Define test methods according to state of the art or relevant guidelines and ensure availability of required devices
- Selecting and coordinating with national and international study sites and service providers; establishing long-term clinical partnerships with international study sites
- Drafting contracts with clinical partners in coordination with the legal department including negotiation of investigator fees
- Preparation and submission of applications for approval of clinical studies to authorities and ethics committees.
- Organization and execution of clinical studies with coordination of all parties involved for planning and meeting timelines, milestones and budgets, reporting on project progress, preparing presentations to management on project/study results
- Identify and assess risks and challenges and derive appropriate preventive and corrective measures. Monitor success of measures used
- Responsibility for completeness and quality of essential study documents and appropriate archiving thereof
- Manage statistical analysis plan, statistical analysis and evaluation of clinical results analysed and preparation of study reports. Contribute to / review scientific publications, develop and define standard treatment recommendations and indication statements in collaboration with the CA manager.
- Review and evaluate new regulations, guidelines, standards for clinical studies; derive measures and adapt existing clinical affairs process description
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Oberkochen, Germany