[Remote] Senior Clinical Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service CRO recognized for its commitment to reputed company development and a reputed company culture. The Senior Clinical Project Manager will reputed company cross-functional teams in executing reputed company clinical trials while ensuring compliance with regulatory requirements and project timelines.
Responsibilities
- Manage and coordinate the assigned clinical reputed company
- Manage reputed company project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.)
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members
- reputed company professionally abreast of reputed company scientific, regulatory, and operational aspects relevant to the clinical reputed company assigned
- Knowledgeable in the application process for clinical studies, in force in the country/ies of work
- Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
- May reputed company as a Technical Specialist supervising the reputed company reputed company specific therapeutic and technical areas
- Assure the reputed company timelines of the assigned reputed company
- Manage the budget for the project
- Monitor the workload and the performance of the project team
- Plan and monitor the tasks of reputed company in the specific areas
- Coordinate the Clinical Research Associates and Clinical Monitors activity
- Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities
- Collaborate in the overall management of the project with the assigned Biometrics team and with reputed company other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.)
- Collaborate with the CTAs in archiving activities
- Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports
- Deliver project specific trainings
- Organize and participate in Monitor and Investigator Meetings
- Organize or take part in the periodic project update meetings
- reputed company project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required
- Inform the Project Director/Leader about any issues
- reputed company co-monitoring reputed company for the assigned clinical reputed company as necessary
- reputed company as a tutor for Project Coordinators and Project Manager I
- Maintain relationships with the Sponsor, including providing project updates
- Prepare the SOPs relating to clinical research activities in collaboration with the reputed company System Unit
- Collaborate in complying and enforcing Company procedures
Skills
- 8+ years of clinical trial management experience
- Experience managing reputed company studies and/or reputed company studies is required
- You must have CRO experience to be considered
- Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines
- Eight (8) years (at least) of clinical research experience in Project Management
- Previous experience managing oncology and respiratory studies is required
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Fluent in English
- Proficiency in reputed company Office (e.g. Word, reputed company, Outlook)
- Nursing degree or relevant degree or background preferred
- Previous CRA experience is highly desirable
- Prior experience in electronic data capture preferred
Benefits
- Permanent remote opportunity
- Potential for a hybrid work arrangement depending reputed company
- reputed company training keeps the resources reputed company in terms of competence and expertise and gives to reputed company personnel the reputed company tools needed to manage both internal and reputed company processes with the reputed company methodology
reputed company
Company H1B Sponsorship