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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

The Study Design and Programming Manager

Live

What you will do

Let’s do this. Let’s change the world. Job Description

The Study Design and Programming Manager will report to the Senior Manager, System Study Services and will serve as a co-lead over the Study Design and Custom Function Programming Operation. They will be responsible for ensuring that we deliver database builds and maintenance activities in support of our Clinical Study Teams. This role supervises a team that is responsible for building and maintaining our Rave Clinical Trials Databases and programming Edit Checks based on the Data Management Plan. Additionally, this role will have cross-operational interactions between various teams within the CSAR System Study Services group including participation in key operations/activities, where leading departmental or cross functional initiatives or projects is required.

The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results with functional service providers, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and result oversight of external vendors or partners.

The successful candidate will be adept at handling a high-quality, high-availability technical service area within the clinical trial conduct space. They will be a strong leader with demonstrated ability to influence collaborators, while also acting as an individual contributor on study specific and general projects or operational work. Proven capability of overseeing and effective partnership with external vendors or service delivery partners in delivering systems support or study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, eCOA, wearables/mHealth, and other data collection devices).

The primary results for the Study Design Operational area include supporting Rave Database builds, Maintenance activities, Edit check and Custom Function programming, Proof of concept builds to support large scale projects. The operational lead will be accountable for the service delivery oversight and process compliance supported by a Functional Service Providers (FSP) or other external service providers.

The position is expected to partner effectively with other CSAR Systems Leads and cross functional leads to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality. Also, will serve as key process authority representing the Study Design in support of key processes, functional governance groups, and/or cross functional systems integrations.

Key Responsibilities

• Serves as the co-Operational Lead for the Study Design operational area within the Clinical Systems and Analytical Reporting.
• Accountable for quality delivery (Quality Oversight Plan) and competencies within the Study Design service area.
• Partner with FSP Operational Leads in maintaining consistent compliance to established Amgen processes and standard methodologies for the FSP results.
• Partner with FSP Operational Leads in handling CAPA’s related to the Study Design quality delivery or compliance issues.
• Lead or give to key or interdepartmental initiatives / projects with particular focus in system or process improvements.
• Serves as the document author for process SOP or manuals and owner for the corresponding companion guides and tools (e.g. templates, checklists etc).
• Facilitate rapid issue resolution through others (internal forces and FSP).
• Effectively partner with cross functional support groups (i.e. Amgen IS, EDC Operations) to address potential systematic or technical quality issues.
• Assist in audit preparation and responding to audit findings (internal or external).
• Act as process SME and provide support to internal staff or providers.
• Authorize appropriate systems access requests for FSP Study Design and Custom Function staff members.
• Assist in the design and development of study specific technical documents
• Support the internal team in managing project related timelines and associated activities
• Work with external resources to lead the creation and implementation of user acceptance tests Identify and track study-related technical issues to resolution
• Provide a supportive framework for continuous process and quality improvements
• Act as a conduit between various functions within System Study Services and help drive end to end efficiencies in data collection standards through internal and external parties to facilitate internal results to our GSP team.

Other Responsibilities include, but are not limited to, the following:

• A leader for specific CSAR focus areas in partnership with Functional Service Provider; e.g. study database design and build, eCOA, etc.
• Lead or supply to key or interdepartmental initiatives / projects with particular focus in system or process improvements.
• Ensure efficient and consistent use of EDC
• Ensure system use is aligned with the established procedures or standards and aligned to industry best practices
• Identify, recommend, or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and cultivate a collaborative working environment.
• Ensure documentation support CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.
• Assist in preparing for and responding to audit findings (internal or external).
• Act as SME and provide coaching and mentoring to internal staff or providers.

Knowledge

• Good Clinical Practice
• Clinical Systems landscape and/or Analytical platforms/reporting technology
• Understanding of handling and providing oversight of operations with FSP/MSP or other vendor service provider model.
• Drug development and clinical trials processes
• Clinical trial databases and applications
• Systems development lifecycle
• Project planning and management
• Collaborating and leading global cross-functional teams (team/matrix environment)
• Quality management and Risk Analysis
• Regulatory filings and inspections
• Process improvement methodologies
• Oversight of external suppliers
• Setting goals and training plans to improve talent management/career development of staff

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. This professional we seek is a person with these qualifications.

Preferred Qualifications

• 7 years work experience in data management in the Pharmaceutical or Biotech arena
• proven ability in a global organization
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc)
• Bachelor’s Degree in life science, computer science, engineering, business or related field
• proven experience in clinical development including extensive Medidata Rave Study Build and Custom Function experience
• Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO/eCOA or other related technology in the pharmaceutical/biotechnology industry
• Knowledgeable in Good Clinical Practices, and FDA regulations necessary
• Project management and technical expertise, attention to detail, and excellent documentation and communication skills
• Project Management Certification preferred
• Previous vendor management experience preferred
• Excellent time management and organization skills
• Have sound problem resolution, judgment, and decision-making abilities
• Be able to work well in a team-based environment with minimal supervision

US Candidates - Basic Qualifications

• Master’s degree & 3 years of clinical experience OR
• Bachelor’s degree & 5 years of clinical experience OR
• Associate degree & 10 years of clinical experience OR
• High school diploma / GED & 12 years of clinical experience

Canada – Basic Qualifications

• Bachelor’s degree or equivalent in life science, computer science, business administration or related team

Thrive

Some of the vast rewards of working here

As we work to develop treatments that deal with others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A diverse and broad community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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