Clinical Data Mgmt Manager
Career Category
Clinical
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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
Let’s do this. Let’s change the world. In 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: Bachelor’s 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 control strategies;
2. Overseeing the design and development of electronic case report forms (eCRFs) and clinical trial databases;
3. Leading data cleaning activities to rectify identified issues and discrepancies;
4. Ensuring data management activities comply with regulatory guidelines, including Good Clinical Practice (GCP) and CDISC standards;
5. Preparing and contributing to regulatory submissions and audits;
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 candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-232610.
Job type: Full Time position. The annual salary range for this position in the U.S. is $121,739.00 - $143,337.00 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.
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.
.
Apply Now
Apply Now
Clinical
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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
Let’s do this. Let’s change the world. In 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: Bachelor’s 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 control strategies;
2. Overseeing the design and development of electronic case report forms (eCRFs) and clinical trial databases;
3. Leading data cleaning activities to rectify identified issues and discrepancies;
4. Ensuring data management activities comply with regulatory guidelines, including Good Clinical Practice (GCP) and CDISC standards;
5. Preparing and contributing to regulatory submissions and audits;
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 candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-232610.
Job type: Full Time position. The annual salary range for this position in the U.S. is $121,739.00 - $143,337.00 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.
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.
.
Apply Now
Apply Now