clinical site and study manager.

The company offers the following benefits for this Clinical Site and Study Manager (CSSM) role:

• competitive remuneration package
• dynamic working environment, focused on company’s values
• the opportunity to work on the some of the most prestigious, ground-breaking and challenging  projects
• real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company

Key Accountabilities:

• deeply acknowledges and strictly follows SOPs, ICH-GCP guidelines and appropriate local and international legislation
• as soon as a new clinical trial is delegated to him/her, the CSSM has to study and completely comprehend the protocol and other study related documents, as well as bibliography on the disease under study.
• "owns" the protocol and acts as Study Manager.
• implements company strategy and policies.
• receives and reviews the final protocol and CRF
• ensures the correct translation of the study related documents to local language, if required.
• acts as liaison between the CRO and the client (sponsor or investigator).
• collaborates with OD and COD to arrange study logistics, resources and planning and more specifically in:
• preparing the study plan at the beginning of each study.
• providing the specifications of the study team and the resources required for the study implementation
• acts as the lead team member assigned to the trial
• ensures the daily compliance of study team to the initial study plan and set standards
• arranges study team meetings for the review of study progress.
• works close with the SSUS for the submission of the study files to the National Ethics Committee and Regulatory Authority
• in collaboration with the CTA prepares, checks and updates the Clinical Trial Files throughout the study
• ensures that the centers are supplied with adequate study medication
• performs monitoring and remote monitoring visits at sites and ensures adequate monitoring of the clinical trial conduct. Prepares reports to document all discussions, measures and actions made during a monitoring visit or a telephone contact and sends summary of these reports to the investigators (follow-up letter). Informs sponsor about any comments made by investigators related to the design of the trial or procedures that may explain difficulties at this site.
• in case of an audit or regulatory inspection, informs and prepares the site and facilitates the procedure. In collaboration with the appropriate managers supervises that the corrective actions are performed in accordance with the agreed CAPA.
• completes all  administrative responsibilities within the set timelines 
• performs co-monitoring visits for training purposes or for the oversight of his/her study team members.

The ideal candidate for the Clinical Site and Study Manager (CSSM) role will be expected to have the following:

• life Sciences or related degree
• at least 5 years of experience
• thorough understanding of country level regulations, ICH and GCP guidelines
• thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
• fluency in written and oral English
• computer literacy

at least 5 years of experience is mandatory

If this sounds like you, we want to hear from you today! Should you need additional information,  please contact me Vasia Christodoulou 6941411215.

Please note that for transparency and equity reasons, only those applications made online via our site will be assessed. After the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. ​All applications are considered strictly confidential.