Study Management Senior Manager
Location:
South San Francisco , California
Posted:
February 07, 2017
Reference:
R-31807
Amgen Early Development group is looking for a Study Management Senior Manager to be accountable for the strategic planning, execution, management and reporting of early development clinical trials. The Study Manager is the lead member of one or more cross-functional clinical study team. These complex programs focus on the rapid development of emerging New Molecular Entities (NMEs) with limited clinical data, and as such, require implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, including biomarkers and diagnostics. The Sr. Study Manager is accountable for leading a group of 10+ study managers and ensuring the efficient delivery of global clinical studies and provides leadership in the implementation of the early development portfolio and collaborates expertly and encourages innovative thinking amongst peers and study team members.
Responsibilities:
Coordinate the development, and contribute to the writing and review of study related documents, including Study Concept Document and Protocol
Contribute to the writing and review of study related documentation, including safety and regulatory related documents, Clinical Study Report and publications
Work with the Clinical Study Planner (CSP) to develop/maintain study timelines
Participate in the ongoing evaluation of the feasibility of the program strategy and study timelines, amending the timelines as appropriate
Contribute to the selection of clinical investigators
Discuss study design with investigators/key opinion leaders (where relevant)
Organize and where appropriate, lead Investigator meetings
Accountable for ensuring all site and study team members are trained on the conduct of the study
Lead study teams
Approve site initiation regulatory documents, approve site visit report and provide overall management of study related activities
Manage Dose Level Review meetings, communicate and ensure decisions are effectively implemented
Provide input into the development and approval (as required) of study-specific documents including (e)CRFs, SAP, DMP, DTP
Contribute to the study level forecast of investigational product and support the creation of the study logistics plan
Ensure that all study personnel understand the study timelines and deliverables
Monitor the execution of the clinical study against the specified timelines, deliverables, and budget
Communicate study status to management and update relevant systems
Contribute to the review and interpretation of study results
Oversee the identification, selection, set-up, and management of CROs and vendors, including approval of invoices
Train and supervise direct reports and provide performance management/opportunities for career development and conduct performance reviews
Contribute to program/project resource planning
Partner with cross functional teams for ongoing process improvement/ planning and strategizing
Basic Qualifications:
Doctorate degree & 2 years of Clinical Research experience
OR
Master's degree & 6 years of Clinical Research experience
OR
Bachelor's degree & 8 years of Clinical Research experience
OR
Associate's degree & 10 years of Clinical Research experience
OR
High school diploma / GED & 12 years of Clinical Research experience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
9+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company
Previous management experience of direct and indirect reports
Experience in oversight of outside vendors (CRO's - study management and monitoring, central labs, imaging vendors, etc.)
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, or disability status.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.


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