Description
My Client, a leading Biopharmaceutical company is currently seeking a Clinical Project Manager in Lausanne for 6 months. This is a global pharmaceutical company with presence in varies countries around the world. They are well-known for their ability in pioneering science. They operate an open-minded environment, particularly within clinical study teams. This is an international, English-speaking environment.Principal Responsibilities
- Drive the completion and customization of site level plans and process flows with the CPLs and the CRO teams as appropriate such as site regulatory package collection plan, site monitoring plan, data review plan. Ensure plans are updated as needed and ensure submission of these to the central files.
- Manage the QoL work stream in study start-up which includes-Sourcing, budgeting and contracting applicable QoL instrument licenses for a particular protocol in participating countries from QoL vendors and work with translation vendor on obtaining translations and organize printing in time for IRB/EC submissions/FPFV
- Work with Clinical Research Organizations (CRO) monitors in proactively maintaining / up-dating essential documents as required; to ensure compliance with protocol and regulations
- Contact sites as needed for data entry/data quality concerns and alert CRA (CRO personnel) of any issues prior to the next scheduled monitoring visit
- Ensure any site level CAPAs in place are adhered to per COL's direction
- Assist with establishing and maintaining of tracking systems for study materials, QoL CRFs and query resolutions in accordance with subject enrollment and study timelines
- Assist with study start-up activities including development of the first draft of the ICF
- Assist with the QC of protocol, ICF and CSR documents that include data interpretation and escalation to legal or other cross-functional teams as required
Qualifications
- Min 6 years clinical research experience in the pharmaceutical industry, CRO or in a hospital setting
- Highly skillful with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail and eCRF systems.
- Good oral and written communication and interpersonal skills
- Proficiency with Good Clinical Practices (GCPs), International Conference for Harmonization (ICH) Standards, and FDA Code of Federal Regulations for clinical trials
- Knowledge of clinical research study design.
- Proven ability to manage and prioritize multiple tasks remaining focused on personal objectives and working effectively in a multi-disciplinary team or independently when required
- Mentor junior staff to share their vision and support them to reach a common goal
Education
- Bachelor's Degree or International equivalent is required, preferably in Science or Health Related field. Certification CCRA/P is desirable.
If you are interested, please get in contact with me. I look forward to hearing from you.
Sebastian Spaniol
s.spaniol'@'realstaffing.com