In this role, you will lead the core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making.
In this role, the selected candidate will oversee the review and execution of the Lab Manual for sample management, provided by the contracted vendors; partner with Clinical Delivery manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines.
In this role, you will be responsible for independently managing multiple clinical trials in multiple indications; manages vendor and site related issues; and ensures studies are conducted in compliance with GCP/ICH guidelines.
In this role, you will communicate with study investigators in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
In this role, the selected candidate will be responsible for the performance of and/or oversight of critical patient care activities, including scheduling, staffing, intake, physician communications, billing and reimbursement processes and overall compliance.
In this role, the selected candidate will be responsible for leading a team through coaching, training, motivating and coordinating activities for team members; drive performance management through coaching, motivating team members, providing feedback and direction against stated goals, writing and delivering performance evaluations and taking corrective action as necessary to drive individual and/or team performance.
In this role, the selected candidate will provide appropriate oversight of the operating model and associated process for vendor outsourcing strategy and contracts (both clinical program and non-clinical program related) by collaborating with internal and external stakeholders.
In this role, the selected candidate will provide ongoing case management of all patients assuring an accurate evaluation and treatment plan, maintaining our quality model, and utilizing services appropriately to achieve optimal outcomes.