Clinical Site Manager (FSP)

Key Accountabilities:

Site Engagement Deliverables

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of clinical trials.

• Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of Clinical trials.

• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of Client and its activities thereby increasing their desire to partner with Client.

• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to Client forums, boards and/or discussions.

•  Interact/train new investigators to work on clinical trials.

Monitoring Deliverables

• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection.

• Primary contact for sites regarding study-related issues.

• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.

• Interact/train new investigators to work on clinical trials.

• Attend key therapeutic trainings/meetings and/or industry trainings.

• Support Clinical Project Manager in management of the study, including but not limited to:

• • Vendor management

  • Training o Logistics

  • Selection of sites o Maintenance of study tracking o Oversight of eTMF

• Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.

• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.

• Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/ participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.

• Prepare and/or review monitoring tools, e.g. monitoring manual.

• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.

• Review and approval of site regulatory packages.

• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.

• Contributes to updates of clinical program information, e.g., annual safety updates

• Investigator’s Brochure, and on query resolution, as needed, etc.

• Depending on trial setting:

• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.

• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.

• Conduct co-monitoring visits with Client internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

• Utilizing all applicable Decentralized Clinical Trial (DCT) methods.

• Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the Client innovation/ Technology Transformation Implementation (TTI) Teams.

• Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.

• In collaboration with Clinical Project Manager /study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

Skills:

• Strong facilitation skills.

• Good collaborator.

• Clear and articulate verbal, written and presentation skills with excellent command of English and local language.

• Excellent verbal and written communication.

• Ability to operate effectively within an international and rapidly changing environment.

• Ability to supervise monitoring and related activities in a clinical trial.

• Ability to work without close supervision; ability to work under stress and within a team environment.

• Proficient in MS Office Suite.

• Curious and agile, “nothing is impossible” mentality.

• Ability to have scientific discussions with Investigators and Site Personnel.

• Able to problem solve.

•  Ability to analyze, synthesize, and clearly present information to individuals and groups.

• Ability to travel at least 50% of the time (including overnight stays, possible global).

Knowledge and Experience:

• A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies) .

• At least three years’ experience in monitoring of trials in clinical development environment, preferably in phase 2-4 if responsibility for phase 2-4.

• Strong Knowledge of GCP and ICH Guidelines.

Education:

• Strong Knowledge of GCP and ICH Guidelines.