At bristol myers squibb, we are inspired by a single vision transforming patients lives through science.in oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change.
we bring a touch to every treatment we pioneer.
join us and make a difference.responsibr the oversight of the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (sops), good clinical practice (gcp) and the applicable regulatory requirement(s).act as one of the points of contact at a site levr internal and rnal stakeholders.identifies new potential investigators, through ongoing collaborationswith internal and rnal stakeholders.assesses potential investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
develop site relationships (incl.
contract research organization related issue management and non
proactively identify and resolve potential problems at both site and country level.
engage with clinical trial manager and/or line management to assist in the resolution of more complex issues.
proactively seek to enhance communication skills with both internal (global level) and all relevant rnal parties and coaches others to do the same.
contribute significantly to study team and coaches site staff to enhance site and hub performance.
serve as a key resourr colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/rmal presentations.
may assist line management with conducting monitoring authorizations and ongoing assessments.may be assigned as a lead ctr a study locally and as determined by rco country/cluster leadership.key stakeholders/contacts describe this positions key internal matrix relationships and key rnal stakeholders/clientsinternal stakeholders;clinical scientist, clinical trial physician, global trial manager, clinical trial manager, clinical trial (cta), site relationship managers, study start-up specialists, site contract leads, vendor operations managers, regional clinical compliance leads, central data reviewer (cdr), data management leads, line managers (lm), head of clinical operations, local regulatory and local medical affairs teamrnal stakeholders.principal investigator, sub-investigators, study coordinators, research nurses, research managers, data managers, pharmacists, ethics committees, vendors, moh personnel (where applicable), gcp office (china only)bachelors degree required preferably within life sciences or equivalent.
valid drivers license (as locally required)clinical trial monitor:
3-5 years of relevant clinical research importante empresa, able to work independently.basic to good knowledge of ich/gcp guidelines and applicable local laws and regulations (health authorities)which govern clinical trials.knowledge and understanding of clinical research processes, regulations and methodology understanding of clinical landscape with practical knowledge of a variety of medical settings and medical records managementorganization and time management skills.ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations good verbal and written communication skills (both in english and local language).manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territorequently/often travel.
significant travel outside of region is occasionally.