Trial Master File (TMF) Operations Manager

Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? You?ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission?to serve patients?drives all that we do. It is key to our becoming one of the world?s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Trial Master File (TMF) Operations Manager Live What you will do Let?s do this. Let?s change the world. In this vital role you will be involved with management of records for the Trial Master File (ICH GCP requirement). We are seeking a proactive individual, with a ?can do? attitude who will support clinical trial study teams ensuring a complete and contemporaneous TMF all times in line with Inspection Readiness. You will provide... records management advice including management of individual projects in line with the function strategy and identify, manage, escalate and resolve issues related to records management. Responsibilities: Delivering consistent, high quality record management advice for all clinical trial content to ensure compliance Mentoring staff to ensure awareness and consistent following of current operating procedures and best practices Maintaining business relationships cross-functionally within region and globally Representing TMF Operations as appropriate, on process improvement initiatives and projects Development standards authorship or review Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Clinical Trial Operations Manager with these qualifications. Basic Qualifications: Master?s degree & 3 years of directly related experience or Bachelor?s degree & 5 years of directly related experience or Associate?s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience Preferred Qualifications: 5 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) Experience in use of Veeva Vault clinical electronic Trial Master File (eTMF) system Management experience Doctorate degree Knowledge: Strong understanding of global regulatory requirements and guidelines for conducting clinical research and safety monitoring/reporting Knowledge of relevant GCP, external and internal regulatory requirements/guidelines Experience managing projects in a matrix organization Ability to network and build relationships to maximize organizational function and capabilities Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates? professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Salary Range: $119,349 - $134,555 . Salary Range - Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen