Career CategoryClinical Development
Job DescriptionGlobal Trial Manager Duties: Monitor work productivity or quality to ensure compliance with standard operating procedures; Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation; Oversee resolution of audit findings to ensure accuracy, completeness, or proper usage of clinical systems and data; Oversee the quality and scientific integrity of clinical operations for studies at a global level; Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables; Lead the Clinical Study Team to drive effective decision making; Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables; Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines; and Management of study budget and timelines; Management of vendors to the required standards. May Telecommute. Supervises Direct Reports.
Requirements: Master's degree (or foreign equivalent) in Biotechnology, Biology, Project Management or a related field & 3 years of experience in the job offered or in a Trial Study related occupation.
Exhibit project management skills including leading study level planning of the overall clinical operation and maintaining study timelines;
Experience with operational conduct of a study in startup, conduct, and close out phases, including but not limited to site identification, evaluation, selection, activation, and closeout;
Development and review of clinical study-related documents;
Vendor Management to ensure on time startup and delivery of services needed to conduct the clinical trial;
Operations of clinical trials including: Study Planning & Trial Start-Up, Site Management & Oversight, Patient Recruitment & Retention, Trial Conduct & Data Quality, and Trial Budget & Financial Management;
Resolving issues or risk mitigation for clinical trials including: slower projected enrollment, high rate of protocol deviations, safety concerns involving the investigational product, data quality problems, and site operational or quality concerns, budget or timeline variances; and
Implement and conduct clinical trials in accordance with sponsor procedures and ICH-GCP guidelines.
Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-248055
Job type: Full-Time position. The annual salary for this position in the U.S. is $185,806.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
.
