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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support:

Job Category:

Professional

All Job Posting Locations:

Madrid, Spain

Job Description: Position Summary:

An Associate Site Manager Early Development 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 (ED&CP) studies. An Associate 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), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring, and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Trial Delivery Leader (TDL) to ensure overall site management while performing trial related activities for assigned protocols. An Associate Site Manager may contribute to process improvement and training.

Principal Responsibilities:

1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
2. Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed appropriately.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. In collaboration with Manager Site Investigational Product Specialist (SIPS) and Manager Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered, and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
9. Ensures site staff complete the data entry and resolve queries within expected timelines. Sets up plans to improve data entry in collaboration with TM when needed.
10. Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blinding when applicable.
11. Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) 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.
12. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
13. Fully documents trial related activities with respect to study monitoring. Writes visit reports and addresses follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
14. Reviews investigator site file for completeness and ensures archiving retention requirements.
15. Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
16. Attends regularly scheduled team meetings and trainings.
17. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and ED&CP knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
18. Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).
19. Prepares trial sites for close out, conducts final close out visit.
20. May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
21. May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
22. Tracks costs at site level and ensures payments are made, if applicable or collaborates with CCS in charge of site payments.
23. Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, study coordinators, other site staff and key contacts in ED&CP.
24. Coordinates site level lessons learned activities.
25. May contribute to process improvement and training.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Principal Relationships:

Primary Reporting Structure: Reports to Functional Manager (FM).
Primary interfaces: FM, CTAs, SMs, TMs. SIPS, PIPS, Compliance Managers/Specialists, Local Safety Officer.
Other Internal Interfaces: Contract and Compliance Services (CCS), TDM/TDL, Therapeutic Area study team (e.g. Study Responsible Scientists and/or Study Responsible Physicians), Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Business Operations & Quality Leader and others as required.
External Interfaces: Investigational Site Staff and others as required.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required.
• 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. Experience in monitoring ED&CP studies is preferred.
• Specific therapeutic area experience/knowledge may be required.
• Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Proficient 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 local country language and English. Good written and oral communication skills.
• Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
• Ability to work on multiple trials in parallel in different disease areas.

Required Skills: Preferred Skills:

Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management