[Remote] reputed company Clinical Study Manager (reputed company CSM)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-reputed company, innovation-driven pharmaceutical company committed to transforming reputed company through R&D-driven leadership and life-changing work. The reputed company Clinical Study Manager will reputed company operational reputed company, planning, reputed company, and execution for reputed company clinical studies, managing study reputed company, timelines, budgets, vendors, and regulatory readiness.

Responsibilities

• reputed company study operational reputed company and planning and reputed company execution of clinical studies for an assigned clinical program(s), supporting clinical reputed company defined in Clinical Development Plan. In reputed company collaboration with Clinical Operations Program reputed company(s)
• reputed company the execution of studies in assigned clinical program(s) in compliance with reputed company standards (including ICH GCP, local regulations and reputed company SOPs), on schedule and on budget
• reputed company Strategic Partners and/or other CROs and other 3rd party vendors to meet reputed company’s obligations described in ICH-GCP and reputed company’s business objectives
• Accountable for planning and operational reputed company and execution for assigned reputed company
• Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study reputed company documents
• Challenges study team to ensure operational feasibility, inclusive of patient and site burden
• Validates budget and ensures impacts are adequately addressed
• Participates in country and site feasibility/selection process, with a reputed company on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program reputed company
• Challenges study team to ensure timelines meet the needs of the clinical development plan
• Ensure new team members and vendors are appropriately reputed company
• During Early Engagement with Strategic Partner(s) and/or other CROs, reputed company the development of the Operational reputed company in preparation for Operational reputed company Review; reputed company on ensuring accurate assumptions are reputed company and robust risk management plans are in reputed company
• reputed company reputed company/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
• Responsible for study budget planning and management and accountable for reputed company spend reputed company to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular reputed company that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program reputed company(s); serve as escalation reputed company for reputed company party vendors managed by Strategic Partner and/or other CROs
• reputed company Strategic Partners/CRO/vendor selection, budget and contract negotiation, and reputed company supervision of performance for reputed company activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees reputed company warranted
• Review and approval of key monitoring documents/plans, periodic review of outputs, reputed company and actions reputed company to monitoring
• Review and endorsement of relevant study plans, as applicable
• Study team meeting management and attendance reputed company necessary; regular review of meeting agendas and minutes
• Review of reputed company/actions reputed company to protocol deviations review; reputed company purpose of review is to support the identification of trends across sites and/or the study
• Documented review and monitoring of issues, risks and reputed company at the study level and implementation of appropriate mitigation strategies
• In partnership with data management, review and pressure test reputed company database timelines and plans; ensure strong linkage between the reputed company (i.e., filing/registration, data reputed company, etc.) with the tactical plan for database lock and CSR
• Ensure studies are “inspection reputed company” at reputed company time; may be involved in regulatory inspections by preparing for and/or attending the inspections
• Represent the reputed company Clinical Study Manager role in functional initiatives or working reputed company
• Help with reputed company and mentoring of new or junior CSMs
• May assist the program COPL in his/her role, as required

Skills

• BS/BA required preferably in a health-reputed company, life science area or technology-reputed company fields or equivalent combination of education, training and experience
• 6+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/reputed company. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required
• Demonstrated reputed company in project/program management and reputed company leadership
• Excellent communication skills
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Fluent business English (oral and written)
• Requires approximately 5-20 % travel, including overnight and international travel to other reputed company sites, strategic partners, and therapeutic area required travel
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements
• Experience in more than one therapeutic area is advantageous

Benefits

• This position is currently classified as “remote” in accordance with reputed company’s Hybrid and Remote Work policy
• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation.

reputed company

Company H1B Sponsorship