Clinical Trial Oversight Manager

Amgen - Mississauga, ON (il y a 30+ jours)

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Career Category
Clinical
Job Description

Title: Clinical Trial Oversight Manager

Reports to: Sr. Manager, Development Operations

Location: Mississauga Head Office

JOB SUMMARY

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 to improve health outcomes and improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Our culture is what makes Amgen a special place to work. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Take a few minutes to hear what some of our current staff members are sharing about working at Amgen. Click HERE

The Clinical Trial Oversight Manager (CTOM) represents Global Study Operations – Site Management (GSO – SM) and is part of the local Global Operations Management Team. The CTOM maintains an effective collaborative partnership and assures overall quality of work performed by the Functional Service Provider (FSP) staff (CRAs, CTAs and LMs) in support of Amgen sponsored clinical trials. The CTOM is also the line manager for the Contracts, Budgets, and Payments (SCBA) team, locally.

Responsibilities

Primary point of contact for FSP vendor for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
Provides support of clinical study execution
Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross-functional environment
Oversight of the site contracting, budgeting and payment process
Line Manager of SCBAs

Key Activities

Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials
Collaborates closely with SM-FSP Line Manager to ensure appropriate level of their staff oversight is deployed
Supports FSP staff onboarding and training
Supervises staff involved in local site contracting and budget management, insurance and payment process
Manages SCBA onboarding and training
Point of escalation for all stakeholders to support resolution of issues e.g. Quality, staff turnover and performance concerns
Works with SM-FSP vendor to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable
Involved in local and global site management and cross-functional stakeholder collaboration
Actively participates in role forums including local and global functional and cross-functional initiatives

Basic Qualifications

BS or MS degree or RN

Preferred Qualifications

Work experience in life sciences or medical field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
Experience in a project leadership role
Experience working with or for Functional Service Provider or Contract Research Organizations
Supervisory Experience
Knowledge of or work experience with a biopharmaceutical GRDCA or QC department

Knowledge

Familiarity with advanced concepts of clinical research
Extensive knowledge of ICH/GCP regulations and guidelines
Strong knowledge of clinical trial operations
Understanding of Functional Service Provider operational model
Computer and system operation skills
Relevant therapeutic area education and training
Detailed understanding of customer service
Demonstrated ability to anticipate and resolve problems

Competencies

Demonstrated ability to work independently with minimal supervision
Ability to work effectively in a team/matrix environment on multiple projects
Excellence in relationship building
Ability to lead and influence in a positive manner
Leadership
Strong interpersonal skills
Excellent organizational and planning skills
Excellent oral and written communication
Language: Business English fluency
Attention to quality and detail
Ability to identify and resolve problems
Flexibility
Ability to write and present clearly using scientific and clinical issues terminology
Attention to quality planning and execution

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview .

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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