・On-going site relationship management in local country to enhance the development & maintenance of long-term relationships with clinical investigators working on studies outsourced to a CRO Partner.
・Develop local knowledge of site (and local SMO) capabilities and past performance, and ensure local site / SMO related information is current.
・Coordinate regular communication with clinical sites to align interactions with investigators,
KOLs, Partner CRO, SMOs and relevant internal stakeholders to assure a harmonized approach to site management.
・In close collaboration with Partner CRO-CRA team and the support of internal stakeholders
such as Vendor Operations Manager, Medical Affairs, RCC and local development leads (Japan/China only):
・Proactively work with sites to resolve issues, answer questions, and manage requests.
・Interact and build professional and collaborative relationships with all study personnel and personnel in order to facilitate meeting current and future clinical trial objectives.
・Anticipate and proactively solve study site problems/issues as they occur. Initiate, recommend and communicate corrective actions as needed.
・Proactively communicate and escalate issues identified at study sites and develop corresponding mitigation strategies and recommended approaches.
・Build and manage site relationships; channel information on trials for respective programs. For Internal Use Only, consult an Human Resource Professional with any questions about what to include or not include in this document.
・Use multiple technologies to foster, maintain, and enhance open communication.
・Keep internal interested stakeholders appraised of identified issues, resolution strategy and outcome as well as insights gained from collaborating with the sites.
・Oversee site-level activities of Partner CRO and provide technical advice where necessary
(particular focus on study start-up and closeout activities)
・Support activities associated with the evaluation and selection of investigational sites, investigators and SMOs in order to develop and build-up company network in a coordinated manner.
・Provide input in to site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.
・Assure that timely communication / correspondence with sites and quality standards are
maintained by the Partner CRO. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements
・Bachelors or Masters Degree within life sciences or equivalent
【Experience: Responsibility and minimum number of years】
・At least 4 years’ experience in clinical research in Pharma, Biotech or CRO.
・Demonstrated experience of working directly with clinical sites and investigators.
・Demonstrated customer service and relationship building skills with clinical sites (on site
・Clinical site management experience, with a strong background in operational aspects of
clinical research and clinical development outsourcing.
【Competencies: knowledge, skills, abilities, other】
・Knowledge of ICH GCP and applicable local regulations governing clinical research along
with basic medical and research knowledge.
・Good networking skills to represent the company with key local stakeholders
・Good written and verbal communication skills: able to interact with all levels of internal and
・Good, influencing and problem solving skills.
・Self-motivated with proactive issue monitoring and management including risk assessment
and contingency planning.
・Possess a combination of critical thinking and operational expertise and efficiency.
・Good verbal and written communication skills (both in English and local language).