Diese Position ist zurzeit besetzt
Interim Site Manager Clinical Operations (m/w)
Nordrhein-Westfalen • Interim
- Serve as primary contact point between the sponsor and the investigational site
- Pharmaceutical Industry - Focus Oncology
Our Client is one of the leading players in pharmaceutical Industries.
- Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary local company contact for assigned sites for specific trials.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges the appropriate destruction of clinical supplies
- Ensures site staff complete the data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintains complete, accurate and timely data and essential documents in systems utilized for trial management
- Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Follows the corresponding Monitoring Guidelines for each assigned trial.
- Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
- Attends regularly scheduled team meetings and trainings.
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities.
- Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types.
- Prepares trial sites for close out, conduct final close out visit.
- Negotiates investigator budgets at site level, if applicable.
- Tracks costs at site level and ensure payments are made, if applicable.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- Act as a point of contact in site management practices.
- Acts as an expert in site management practices.
- Reviews and manages site specific informed consent forms in accordance with GCO SOPs, WIs and applicable regulations
- May also take on responsibility of LTM if required.
4-year University degree in Life Sciences, Nursing, or related scientific field is required. Experience in monitoring ED&CP studies is preferred. A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility. Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. Good IT skills in appropriate software and company systems. Willingness to travel with occasional/regular overnight stay away from home depending on the region. Proficient in speaking and writing the country language and English. Good written and oral communication skills. Flexible mindset and ability to work at a fast pace within small exploratory study teams with accelerated cycle times Ability to work on multiple trials in parallel in different disease areas ! Pure Homebased