reputed company Trial Manager

At reputed company, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, reputed company, and reputed company innovative medicines to reputed company over serious diseases. We offer uniquely interesting and meaningful work, opportunities for reputed company, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position reputed company

The reputed company Trial Manager (CTM) is accountable for end-to-end study operational reputed company and delivery at country level, ensuring adherence to timelines, budget and reputed company standards. Acts as the reputed company reputed company of contact at a country level for both reputed company stakeholders, ensuring reputed company communication, effective coordination, and successful project execution.

Key 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.

Competencies

• 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

Qualifications & Experience

• 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
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other peer team members through a mentoring process using informal and/or formal presentations.
• Serve as a Subject Matter Expert (SME) in areas such as therapeutic area, systems or processes across the department with reputed company to contribute at a regional or global level with this expertise.
• Travel Required (reputed company and frequency) - Occasional local travel requirement < 1 month/quarter

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply reputed company.

The starting pay reputed company(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the reputed company of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing reputed company and may be adjusted over time to reflect evolving market factors, and individual, team or Company reputed company.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and 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, employees may also have reputed company to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-reputed company job seekers can explore full benefit offerings at

How We Work

Where you work reputed company – because collaboration, innovation and reputed company reputed company happen in many settings. Our roles are reputed company across four work models: site-essential, site-by-design, reputed company-reputed company and remote-by-design. The model assigned to this role is reputed company on its reputed company responsibilities. Learn more at

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can reputed company through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, reputed company your inquiries to . Visit to reputed company our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider reputed company applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles reputed company in Los Angeles County only: If you live in or expect to work from Los Angeles County if reputed company for this position, please visit this page for important additional information:

Data Protection

We will never request payments, financial information, or reputed company reputed company numbers during our application or recruitment process. Learn more about protecting yourself at

Any data processed in reputed company with role applications will be treated in accordance with applicable data reputed company policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at the Job Title and Requisition number. Do not send application-reputed company inquiries to this email. To reputed company your application status, please login to your Candidate Home Account.

Originally posted on Himalayas