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Senior Manager Development Operations
AMGENINDIA30+ days ago
Job descriptionAlign and lead country / hub in accordance with Amgen strategy, driving One Amgen. Maintain knowledge of country / hub capabilities and clinical research standard methodologies. Represent GSO-SM in internal and external collaborator interactions. Establish and drive local engagement strategy in coordination with local collaborators to optimize external engagements (e.g. key targeted sites, Patient Advocacy groups, Pharma Associations, Consortiums). Advocate for local study placement strategy in consideration of country / hub strengths and growth opportunities. Drive process excellence, innovation, and continuous improvement to accelerate study portfolio delivery. Support and / or lead local and global process improvement & ground-breaking initiatives. Embrace and be an advocate for change within local and global teams. Shape and foster internal environment for optimal local cluster team collaboration. Monitor overall health and consistency of local cluster teams interactions to enable successful delivery of pipeline molecule programs. Partner with relevant GDO functions to monitor study progress and drive timely local action plans & issue resolution. Point for partner concern for resolution of clinical study related issues & risks which impact delivery or quality of clinical trials and / or patient safety. Accountable for country / hub landscaping activities and operational projections. Required advisor for site selection and country commitments. Ensure timely communication with multi-functional teams to support clinical study execution. Support ISSs execution & partner with medical to design and implement LASTs. Partner with RH to maintain appropriate resource levels and manage within budget. Interpret resource supply and demand and ensure efficient resource allocation. Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness. Interpret analytics to monitor overall country delivery across studies (timelines, enrollment, data flow, TMF). Oversee quality and ensure country / hub deliverables in accordance with ICH-GCP, Amgen standards, and Local Regulations. Support internal / affiliate and site audits and regulatory inspections and drive local CAPA implementation. Doctorate degree AND 2 years of directly-related clinical experience OR Masters degree & 8 to 10 years of directly-related clinical experience OR Bachelors degree (BA / BS / BSc or RN) & 10 to 14 years of directly-related clinical experience OR Diploma & 14 to 18 years of directly related clinical experience AND Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company). Previous management experience of direct reports, including management level staff. M.D., D.O., PhD, PharmD, Masters Degree. 7 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company). Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.). Country clinical operations experience and / or regional study management experience. Advanced knowledge of global clinical trial management. Clinical trial processes and operations. In depth understanding of drug development process, clinical trial conduct, ICH-GCP, and local regulations, requirements, and guidelines. Project and Program management including oversight of quality, study deliverables, budgets and timelines. Various therapeutic area knowledge. Fluency in written and spoken English. Clinical trial management systems and reporting tools.
Career Category
Clinical
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.
Senior Manager Development Operations
What you will do
- Country / hub leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for overall country / hub delivery across studies.
- Develop and drive innovative strategies to promote an optimal clinical research environment in the country / hub.
- Actively partners with multi-functional collaborators to support Amgen and R&D strategies.
Responsibilities
Leadership of GSO-SM team in country / hub
Locally accountable for overall country delivery across studies
Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP) and other local vendors
Risk mitigation and quality management
What we expect of you Basic Qualifications
Preferred Qualifications
Knowledge
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, well support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination Objects in your future are closer than they appear. Join us.
careers.amgen.com
Locations : India - Hyderabad
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Operation Manager • INDIA
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