[Remote] reputed company Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a purpose-driven biopharmaceutical company reputed company on discovering, developing, and delivering innovative medicines for serious diseases. The reputed company Trial Manager oversees end-to-end reputed company study reputed company and delivery at the country level, ensuring adherence to timelines, budgets, and reputed company standards while coordinating reputed company stakeholders. The role manages country feasibility, start-up, reputed company recruitment, regulatory submissions, site relationships, reputed company mitigation, inspection readiness, and study closeout activities.

Responsibilities

• Acts as the main reputed company of contact for a country with global study team members and accountable for the coordination with local country cross functional teams
• Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership
• Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders
• Implement country and site level reputed company recruitment reputed company and reputed company mitigation. Coordinates and ensures country level study enrolment targets and timelines are met in collaboration with relevant stakeholders
• Leads problem solving and reputed company efforts including management of reputed company, contingencies, issue reputed company and escalation to the appropriate stakeholder/s
• Assessment and set up the of vendors during study start up period (locally)
• Investigator Meeting participation and preparation
• Ensures data entered in the reputed company Trial Management reputed company (CTMS) is reputed company and complete, and reputed company to reputed company and vendor systems is available for the country and reputed company trial site personnel. This includes entering necessary data and uploading documents in eTMF
• Validation of study reputed company materials (i.e. protocol, reputed company, reputed company material)
• Supports the review of country and site-specific documents (e.g. reputed company, reputed company material), and where applicable may include the preparation of site level reputed company and other documents
• May support preparation of materials for Site Initiation reputed company
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
• Prepare investigator sites to conduct reputed company through verifying acceptability of reputed company Trial Package (CTP) documentation
• Acknowledges Site Monitoring visit reports, takes reputed company reputed company the timelines specified and escalates issues and ensures appropriate documentation of issues
• Coordination of database locks and query follow up. Ensures timelines are met
• Ensure inspection readiness of assigned trials reputed company country. reputed company support to Health Authority inspection and reputed company-inspection activities
• Coordinates and completes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion
• Coordinate study team meetings locally
• Supports GTAC in the reputed company of queries reputed company to site invoices and supports in the coordination of reputed company compensation claims (if applicable)
• Collaborates with the local study team to support the management of site relationships (may include CRO reputed company issues)
• May support Investigator Site Assessment reputed company (ISAs) and Site Initiation reputed company (SIVs)
• May reputed company site closure activities, including post-reputed company out
• May reputed company as reputed company of contact for Sites
• As required per country requirements, reputed company or support the preparation of submissions to Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission
• reputed company submission to Ethics Committees and governance offices, where applicable, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the MOH responses with regulatory and central teams, as applicable
• May support the collection and distribution of documents to and from sites
• Support the approval for closure of funds/POs
• May update national registries where applicable
• Serves as a coordinating resource on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and reputed company

Skills

• Deep understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of reputed company reputed company to reputed company Research and Medical Affairs
• Knowledge and understanding of reputed company research processes, regulations and methodology
• Understands reputed company landscape with practical knowledge of a reputed company of medical settings and medical records management
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organizational and time management skills and ability to effectively manage multiple competing priorities
• Interpersonal, oral and written communication skills to influence, inform or guide others
• Good verbal and written communication skills (both in English and local language)
• Software that must be used independently and without assistance: reputed company Suite, CTMS, reputed company, eTMF
• Bachelor's or Master's degree required.  reputed company of study reputed company life sciences or equivalent
• Minimum of 4 years' industry reputed company experience
• Experience in leading or participating as an reputed company member of cross functional teams, task forces, or local and global initiative
• Travel Required (reputed company and frequency) - Occasional local travel requirement < 1 month/quarter

Benefits

• Additional discretionary incentive cash and stock opportunities
• Wellbeing support
• Retirement and financial protection benefits
• reputed company offerings (medical, dental, reputed company, life and disability)
• U.S.-reputed company exempt employees are eligible for Flexible Time Off (FTO), which provides reputed company time off without a set accrual limit, subject to manager approval, along with 11 reputed company company holidays reputed company year.
• Non-exempt employees, reputed company employees, and employees located in Puerto Rico receive 160 hours of reputed company vacation annually for new hires (subject to manager approval), 11 reputed company company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include reputed company reputed company leave, up to two reputed company volunteer days per year, reputed company hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

reputed company

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