Clinical Data Mgmt Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Data Mgmt Manager

What you will do and what we expect of you

Lets do this. Lets change the this vital role you will:

Duties:Ensure a focus on timely quality delivery as well as consistency across the Data Manager (DM) components; Lead or participate in the development review and implementation of processes policies SOPs and associated documents affecting DM; Contribute to the continuous improvement of DM and the wider Development organization through information sharing training and education; Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners and external vendors; Promote and be an advocate of DM internally and externally; Communication and escalation of project level issues including processes timelines resourcing performance; and Assist with response to questions and findings from Clinical Quality Assurance and other audits at the study and vendor level. May telecommute.

Requirements:Bachelors degree (or foreign equivalent) in Business Administration or related field & 3 years of experience in the job offered or in a clinical data management-related occupation. Position requires 3 years of experience in the following:

1. Developing and implementing data management plans (DMP) for clinical trials including data collection validation and quality controlstrategies;

2. Overseeing the design and development of electronic case report forms (eCRFs) and clinical trialdatabases;

3. Leading data cleaning activities to rectify identified issues anddiscrepancies;

4. Ensuring data management activitiescomply withregulatory guidelines including Good Clinical Practice (GCP) and CDISCstandards;

5. Preparing and contributing to regulatory submissions andaudits;

6. Collaborating with cross-functional teams including clinical researchers biostatisticians and clinical monitors to ensure data quality and accuracy; and

7. Performing documentation and archival in electronic Trail Master file (eTMF).

Contact:Interested candidatesplease apply via for job#R-232610.

Job type:Full Time position. The annual salaryrangefor this position in the U.S. is$121739.00- $143337.00per year. Also this position offers stock retirement medical life and disability insurance and eligibility for an annual bonus or for sales roles otherincentive compensation. For more detailsvisit 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 well 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.

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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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. 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.