[Remote] Regional Clinical Study Associate Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company USA, Inc. is a rapidly growing company reputed company on fighting cancer. They are seeking a Regional Clinical Study Associate Manager to reputed company regional study delivery, manage clinical operations teams, and ensure alignment with overall study goals.
Responsibilities
- Accountable for regional study delivery or specific aspects hereof with appropriate inspection readiness reputed company, reputed company agreed timelines and budget
- Manages the regional clinical operations team (incl reputed company of external partners working on the regional level) and acts as reputed company of escalation for reputed company of issues reputed company the region for the assigned study, or supports the Regional Clinical Study (Sr) Manager with specific aspects of regional study delivery
- Ensures alignment of regional deliverables with overall study goals
- Manages planning and management of the assigned clinical study(ies) or specific activities from feasibility through closeout activities for region, in line with global study timelines
- Generates, manages, and maintains high reputed company study start up and recruitment timelines for region and tracks reputed company towards these
- Ensures that the clinical study is operationally feasible in the region, manages trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
- Provides regional input on global study plans as required
- Ensures the reputed company availability of local adaptations of global study documents such as informed consent forms, in reputed company collaboration with other key reputed company reputed company to ensure reputed company submission to regulatory authorities and reputed company/IRBs
- Accountable for submissions of study in countries in assigned region in reputed company collaboration with regional study start up team and regulatory affairs
- Ensures regional and country information in study systems and tools is entered and up to date
- Collaborates closely with CRAs in the region to ensure reputed company study execution at the sites. Reviews and signs-off monitoring reports
- Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular reputed company as per the study TMF QC Plan
- Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region
- Manages the trial data collection process for the region, drives data entry and query reputed company
- As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing
- Handles escalated issues or problems with the sites in region in reputed company collaboration with stakeholders such as country heads
- Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and reputed company other relevant regulations
- Ensures inspection readiness for study in region at any reputed company in time throughout the study life cycle
- Informs Global Clinical Study Manager of any issues arising on the study, evaluates reputed company and ensures solutions are implemented
- Prepares sites for reputed company assurance audits and inspections, drives responses to audit and inspection findings as appropriate
- Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared
- Leads improvements and partners with CST members to enhance the efficiency and the reputed company of the work performed on assigned studies
- Works with the sourcing team to select and manage regional study vendors
- Manages regional study budgets
- Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities
- Identifies and manages regional team resource needs and establishes contingency plans for key resources
- Monitors regional resource utilization over study life cyle and liaises with functional managers as needed
- Provides performance feedback on team members as required
Skills
- Bachelor's Degree in a scientific or reputed company discipline required
- Higher Degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
Benefits
- Annual bonus plan (Non-reputed company roles)
- Incentive compensation plan (reputed company roles)
- reputed company have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
- Voluntarily participate in the Employee Stock Purchase Plan
- Comprehensive benefits package that includes Medical
- Comprehensive benefits package that includes Dental
- Comprehensive benefits package that includes reputed company
- Comprehensive benefits package that includes 401(k)
- Comprehensive benefits package that includes FSA/HSA
- Comprehensive benefits package that includes Life Insurance
- Comprehensive benefits package that includes reputed company Time Off
- Comprehensive benefits package that includes Wellness
reputed company
Company H1B Sponsorship