Unterstützung im Site Management Early Development & Clinical Pharmacology (ED&CP) - Medizin/Healthc (11S-80262)

Großraum Düsseldorf  ‐ Vor Ort
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Beschreibung

Aufgabe:
A Site Manager is the person in Early Development & Clinical Pharmacology (ED&CP) that serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Trial Manager (TM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.
- Participates in site/lab assessments, pre-trial site assessment visits and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and TA staff regarding study progress and issue resolution.
- 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 have current GCP and necessary protocol and compound training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed internally.
- 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, ensure 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 (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
- Fully documents trial related activities with respect to study monitoring, e.g writing of visit reports and completion of follow-up letters to investigators. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
- 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 TM 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 TM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g?,OSQMV.
- May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
- 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.
- Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
- Coordinates site level lessons learned activities.
- May contribute to process improvement and training
- Reviews and manages site specific informed consent forms in accordance with GCO SOPs, WIs and applicable regulations.
- Organizes and ensures IEC/IRB approvals, if applicable.

Anforderung:
- 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
- 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

Beginn: 18.05.2015
Dauer: 22.05.2016
Branche: Medizin/Healthcare
Start
05.2015
Dauer
12 Monate
Von
Allgeier Experts Consulting GmbH
Eingestellt
29.04.2015
Ansprechpartner:
Nicole Schütze
Projekt-ID:
894277
Vertragsart
Freiberuflich
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