Clinical Site Manager

Site Engagement Manager

• The Site Engagement Manager is responsible for providing operational expertise to site s through ownership/management of Site Engagement Strategy. The scope of this role includes the following:Define and implement strategies for engaging clinical site s and investigators
• Characterize and understand the attributes of a good clinical site versus a poor performing site
• Engage clinical site s to develop build, and maintain relationships with investigators/staff to ensure continued performance and capitalize on site expertise
• Evaluate, screen and develop high quality investigative site s to support clinical development programs
• Ensure collaboration with key internal & external stakeholders, as well as third party vendor
• Ensure industry best practices consistent with all applicable guidelines and regulations
• Identify business improvement opportunities that overall enhance GCSO’s site engagement capabilities with the guidance of the Head of Site and Patient Solutions (SPS)
• As a member of the SPS team: Collaborate/Communicate on regular basis with SPS Team, GCPM Clinical Team and other relevant stakeholders, including strategic partners, to ensure integration of activities and identification of areas for improvement
• Support internal SPS teams and activities, in identification of quality clinical investigative site s for current and future trials
• Act as internal advisor/partner in all aspects of site engagement supporting site selection, patient engagement and patient recruitment
• Support efficient and effective communication and information exchange across all stakeholders
• Ensure that all SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement
• Travel including some overnight stays, up to 50%
• Required qualificationsThe minimum level of education necessary for this position is a B.S. degree (or its equivalent) in a life science/biological or health related field.
• 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)
• Proven track record of success on cross-functional projects in a global environment. Good working knowledge of GCP guidelines in different regions
• Strong facilitation skills, good collaborator, ability to work in networks and matrix organization
• Continuous improvement mindset
• Results oriented, Outcomes focused
• Ability to analyze, synthesize, and clearly present information to individuals and groups
• Customer orientation and ability to work well with colleagues within and outside clinical development
• Creative “out of the box” thinker with conceptual strengths, who will challenge the status quo to improve
• Clear and articulate verbal, written and presentation skills with excellent command of the English and/or language
• Comfortable with reviewing/understanding clinical protocols
• Excellent verbal and written communication
• Scientific and technical knowledge:
• GCP and regulatory environment
• Medical knowledge and research expertise
• Ability to operate effectively within an international and rapidly changing environment
• Ability to work independently, to solve problems at all levels of difficulty or uniqueness
• Ability to manage conflict and achieve consensus in a group through complex and thorough discussion
• Regular interaction with various management levels on issues relating to site engagement , patient recruitment, etc.