Hobson Prior is currently looking for a Clinical Site Manager for an exciting permanent opportunity at a leading pharmaceutical organisation, based in Poland.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
• You will be responsible for complying with relevant training requirements.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
• Contribute to quality Site Selection through participation 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, as required.
• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Drive study compliance by 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 is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role 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, e.g. On Site Quality Monitoring Visit (OSQMV).
• Ensure timely and accurate CTMS data entries / updates.
• Any other assigned duties.

Requirements:

• The ideal candidate will have a BA/BS degree/Degree in a health or science related field or equivalent industry experience.
• A minimum of 2 years of clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course
• Advanced: 3 to 5+ years of clinical trial monitoring experience.
• Specific therapeutic area experience depending on the services need.
• Strong working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel with overnight stay away from home according to business needs.
• Proficient in speaking and writing in English and the country language where services will be provided. Effective communication skills, oral and written.
• Experience with monitoring and site management of complex Early Phase of clinical development, as applicable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.