Develop clinical study protocols, review and interpret clinical study data; develop clinical study reports and other applicable documents; serve as Medical Monitor, ensure the accuracy and quality of sponsor deliverables, and of all relevant CRD and IDS activities, and compliance with ethical, legal, scientific, regulatory and client standards.
Responsible to implement behavioral Health medical policy, technology assessment and clinical practice standards developed by Magellan corporate and participates in management of the inter-rater reliability process to ensure consistency between reviewers. Provides input regarding the need for modifications and additions to medical policy. May participate on corporate medical policy and clinical guideline committees.
This Director of Medical Monitoring will involve acting as Medical Monitor for numerous Oncology trials.The Director will be assigned as a leader of a group of Medical Monitors within Oncology and/or geographical region.
Position is responsible for managing the value team resources, the clinical consulting services team and driving the consulting services engagements, collaborating with the services leadership, account management and clinical development organizations.
Directs professional and analytical staff to ensure superior data and analytics support for the areas of Utilization Management/Case Management/Disease Management; medical cost analysis, HEDIS and other data mining/analytical projects.
In this role, the selected candidate will be responsible for the development, management and approval of scientific methods for design of clinical protocols, case report forms, guidelines and study reports.
As the Medical Director/Senior Medical Director you will be accountable for all activities of study team physicians for US local trials including design of trials, medical oversight of trial conduct, data interpretation as appropriate and execution of compassionate use approaches as well as ascertaining the medical accuracy and fair balance of medical information in promotional material and learning materials for both internal and external use.
Responsible for the development and appropriate delivery of scientific messaging and education, support of scientific and educational programs aligned with the Medical Plan, delivery of medical and scientific insight back to the Oncology Brand Teams and identification and engagement of key clinical investigators for clinical trials and research partnerships.