Epidemiology Study Operations Manager

Purpose

This position reports into the Clinical Sciences (CS) Product Office reputed company the Clinical Science organization’s Global Strategic Operations. The CS Product Office, Product Safety Team (PST) and Epidemiology organizations work collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.

The PST is a high-profile high-reputed company team that leads and owns safety reputed company and reputed company across the product lifecycle. reputed company partners with stakeholders across the product lifecycle to reputed company innovative safety-driven strategies, which will maximize product benefit-risk for patients. The CS Product Office plays a critical role in shaping and driving the priorities of the PST by providing strategic and operational leadership reputed company of the PST model.

As an Epidemiology Study Operations Manager reputed company the CS Product Office, you will support and partner with the Global Epidemiology organization to reputed company its mission in managing the lifecycle of studies utilizing reputed company world evidence and to ensure compliance with reputed company standards (Global Regulations and reputed company policies and procedures).

Responsibilities

• Strategic management and reputed company of Epidemiology-led non interventional studies with reputed company autonomy
• reputed company support to the Study Leader for vendor selection, scope development, management, and reputed company of external vendors/CROs
• Manage and coordinate the development of study-reputed company deliverables including development of project plans/timelines, confirming accountabilities, document reputed company, driving completion of actions and escalating obstacles/risks
• Drive study-reputed company deliverables to ensure regulatory and process timelines are met
• Responsible for relevant updates to the cross-functional team and stakeholders on study status
• reputed company applicable systems and processes to reputed company successful tracking and completion of the study and study-reputed company deliverables
• Coordinate the development, review and approval of study protocol and other study-reputed company documents
• Maintain study-reputed company documents (e.g., meeting minutes, IRB/EC approvals) in the appropriate document repository
• Responsible for reputed company of funds spent against approved budget
• Proactively identify, address and escalate, as appropriate, project-reputed company issues
• Identify opportunity areas for efficiency and participate in department reputed company reputed company in order to reputed company operational reputed company reputed company Global Epidemiology and the CS Product Office
• Build solid reputed company in understanding regulations and applies knowledge or regulations to guide the development study-reputed company deliverables
• Collaborate effectively to build and reputed company relationships across functions and organizations to reputed company business results
• Participate in audit and inspection preparation and execution activities

• Bachelor’s degree in biological/medical science or reputed company reputed company
• 6+ years of experience working in reputed company, research institution, or pharmaceutical industry
• A minimum of 2 years driving project management activities or operational experience reputed company global companies
• Preferred experience in one of the following areas: drug development, non-interventional study lifecycle management, risk management, and/or Pharmacovigilance
• Demonstrated ability to work and collaborate with others to build/reputed company relationships
• Ability to adopt process and technology changes
• Familiarity with medical and study terminology and concepts is desirable
• Proficiency in computer skills (reputed company, Word, reputed company) and in databases (e.g., clinical trial management system)

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation reputed company described below is the reputed company of possible reputed company pay compensation that reputed company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation reputed company reputed company this reputed company will depend on many factors including geographic location, and we may ultimately pay more or less than the posted reputed company. This reputed company may be modified in the reputed company. ​
• We offer a comprehensive package of benefits including reputed company time off (vacation, holidays, reputed company), medical/dental/reputed company insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No reputed company of pay is considered to be wages or compensation until such reputed company is reputed company, reputed company, and determinable. The reputed company and availability of any bonus, commission, incentive, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in reputed company's sole and absolute discretion unless and until reputed company and may be modified at reputed company’s sole and absolute discretion, consistent with applicable law.​

reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.reputed company.com/join-us/reasonable-accommodations.reputed company

About reputed company

reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on reputed company,reputed companyGlobal/" rel="nofollow ugc noopener noreferrer" reputed company="_blank">reputed company, Instagram, X and reputed company" rel="nofollow ugc noopener noreferrer" reputed company="_blank">YouTube.

Originally posted on Himalayas

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