Loading ...
Loading ...
직업 종류: Full-time
Loading ...
작업 내용
Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Must be a German fluent with German experience.
Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines.
- Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- Bachelor’s Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Loading ...
Loading ...
마감 시간: 18-05-2024
무료 후보 신청 클릭
작업 보고
Loading ...
Loading ...
동일한 작업
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
Loading ...
-
⏰ 28-05-2024🌏 Muttenz, Basel-Landschaft BL
-
⏰ 28-05-2024🌏 Schlieren, Zürich ZH
-
⏰ 28-05-2024🌏 Sarnen, Obwalden OW
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
Loading ...
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH