Local Study Operations Sr Manager Job at Amgen (Milan)

Sr Mgr Local Study Operations

In this role, you will lead the skill development of Local Study Operations Mana...

Location

Spain , Barcelona

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio
Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio
Support discussions regarding study placement decisions based on country capabilities and growth potential
Proactively evaluate risks, quality trends, and resource requirements

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Sr Manager Operational Excellence

With over 85 years as an industrial technology leader, Kennametal Inc. delivers ...

Location

United States , Bedford

Salary:

Not provided

Kennametal

Expiration Date

Until further notice

Requirements

Bachelors degree required, prefer STEM or Industrial Engineering area of study
6-Sigma greenbelt or black belt is plus
At least 10 years with demonstrated success in manufacturing, quality, engineering, lean/6-sigma, and /or supply chain experience
Strong leadership, communication, teaching, and coaching skills
5S and visual controls
Standard work
OEE and time study
Muda Hunting
Pull system/ Kanban
SMED

Job Responsibility

Manage the activities of plant operational excellence personnel and lead continuous improvement initiatives within the multi-sites/plants in your region
Implement strategies, frameworks, and methodologies to enhance operational efficiency, streamline processes, and optimize performance on a multiple plants scale
Collaborate with site management and cross-functional teams to identify improvement opportunities, establish and share best practices, and foster a culture of operational excellence
Lead by example in Lean standards and Kaizen principle
Develop the lean competences of sites of the region and help sites to become autonomous in continuous improvement management
Deploy Global Lean Strategies and the associated standards, methodologies, and tools in the responsible sites/plants in region
Work closely with regional manufacturing directors/Plant/Site Managers, and Plant / Site OpEX Managers to define lean priorities, action plans and approaches
Make timely diagnosis of lean methodologies and tools and practice On Job Training on his/her sites
Collaborate with site-level Opex Managers to drive Kaizen workshop execution and monitor progress
Coach Plant operation teams: Plant/Site Managers, Production Managers, Plant / Site OpEX Managers, Production Supervisors et al to deliver training sessions, workshops, and coaching to enhance Lean knowledge and skills within the region

Fulltime

Senior Clinical Research Associate - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

South Korea

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Fluent in English and in the native language(s) of the country they will work in
Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations
Global clinical trial experience
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Demonstrated knowledge of clinical research and development processes
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research
Demonstrated knowledge in disease and technical areas pertaining to clinical studies
Demonstrated ability to support sponsor regulatory interactions/inspections

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed
Partner with SCP to perform investigator site development, coaching and training of site personnel
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

Patient-focused culture
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Continuous Improvement and Process Coordinator

As the Continuous Improvement & Process Coordinator , in a context of strong, su...

Location

United States , Dayton

Salary:

28.46 - 31.45 USD / Hour

Assessfirst

Expiration Date

Until further notice

Requirements

2-3 Years Minimum of Related Experience in Retail/Luxury Supply Chain and Distribution
Bachelor’s Degree required
Strong interpersonal & communication skills, and ability to collaborate efficiently with all levels of the organization
Knowledge of Distribution Center best practices and processes
Ability to work both independently (multitask with little supervision) and in a team environment (cross-departments/functions)
Ability to work under pressure, to anticipate and to adapt
Strong analytical and organizational skills
Customer service mindset
French and/or Spanish language skills are highly desirable
Previous experience at Hermès or another luxury goods retailer

Job Responsibility

Collaborates with local Distribution management on improvements to workflow, process and perform time studies
Responsible for the creation of Standard Operating Procedures (SOPs)
Define Process maps for all departments and activities in Dayton
Create Risk mapping for teams
Identifies and mitigates risks, and drives continuous improvement throughout the supply chain for all other assigned projects (for ex. transportation network optimization, warehouse slotting…) and activities (merchandise vs. non-merchandise, retail vs. E-Commerce…), with sustainability at the core of all options and solutions identified
All other duties assigned by the Sr Manager of Logistics Projects, Sr Director of Logistics and Distribution, or VP of Distribution & Service Center
Oversee and assist in the creation of Standard Operating Procedures, Risk management, process documentation, and continuous improvement

What we offer

Commission and bonus incentives based on sales performance
Medical, Dental, Vision
Life Insurance and Disability
Paid time off (annual vacation of 15 days, 11 company holidays, 3 floating holidays, 2 wellbeing days, and sick & safe time)
Paid Parental leave and transition time
401(k) and Roth Retirement plan with company matching and profit sharing
Various voluntary benefits such as flexible spending accounts, fitness reimbursement, voluntary life insurance
Product discount and EAP resources
Access to Calm App, Health Advocate, Family Building Support and more

Fulltime

Gn&C Sr Engineer

The Amentum Space Exploration Division (ASED) Guidance, Navigation, and Control ...

Location

United States , Huntsville

Salary:

Not provided

Amentum

Expiration Date

Until further notice

Requirements

A degree in Aerospace, Mechanical or Electrical Engineering or related field from an ABET accredited institution is required. Typical experience requirements are the equivalent of a PhD with at least 19 years of experience, a master’s with at least 23 years of experience, or BS with at least 25 years of experience
Must be a US citizen
Proficiency modeling, simulating, and analyzing the performance of launch vehicles, spacecraft, and landers in the time domain using parametric, Monte Carlo, and statistical techniques
Ability to work problems from first principles and integrate subsystem models including Guidance, Navigation, and Control algorithms into larger simulations
Modeling of spacecraft components/subsystems such as: Thrust Vector Control (TVC) actuators, Reaction Control System (RCS) thrusters, slosh, pogo, rigid and/or flexible body dynamics
Experience with modeling, simulation, and analysis of spacecraft rendezvous, proximity operations, and docking and/or landers
Programming in MATLAB, Simulink, Python, and C/C++
Experience performing software development, verification, and validation
Experience performing trade studies, sensitivity, and/or Monte Carlo simulation and analyses related to the control of launch vehicles and/or spacecraft
Familiarity with and an understanding of trajectory and orbital dynamics

Job Responsibility

Model, develop, simulate, and analyze launch vehicle, spacecraft, and lander dynamics and control system performance and stability
Resolve complex problems pertaining to the design, development, analysis, integration, evaluation, testing, and verification of control systems and 6-DoF models and simulations
Develop, modify, maintain, and improve software simulations, tools, and scripts
Periodically analyze HLS partner’ flight data and present findings to NASA management
Create, edit, and debug software written in MATLAB, Simulink, and Simscape
Configure, conduct, and analyze 6-DoF Monte Carlo simulations
Automate Monte Carlo, controls design algorithms, and/or regression processes
Conduct trades studies and/or sensitivity analyses related to launch vehicles and spacecraft control
Mentor junior engineers in conducting control system modeling, simulation, and analysis
Prepare and present technical reports and/or briefings including visualization of results

What we offer

Health, dental, and vision insurance
Paid time off and holidays
Retirement benefits (including 401(k) matching)
Educational reimbursement
Parental leave
Employee stock purchase plan
Tax-saving options
Disability and life insurance
Pet insurance

Fulltime

Sr Associate Regulatory Affairs

The Senior Associate in Regulatory Affairs supports country regulatory activitie...

Location

Czech Republic , Prague

Salary:

742975.65 - 1005202.35 CZK / Year

Amgen

Expiration Date

Until further notice

Requirements

Proficiency in English at B2 level or higher, proficiency in Czech
Basic understanding of regulatory principles
Ability to follow policies, procedures, and SOPs
Teamwork and communication skills
Willingness to learn and develop expertise
Bachelor's degree in a life-science area
Entry-level professional knowledge and/or experience in life-science sector (pharmacy, laboratory, public institution, academia)

Job Responsibility

Participates in preparing the filing plan (MA and lifecycle maintenance) and joins discussions with the local cross-functional team
Contributes to the execution of the filing plan (MA and lifecycle maintenance) for their country(ies) under supervision
Helps prepare regulatory submissions to ensure they are completed on time and meet Amgen's corporate and local regulatory requirements
Assists in preparing and reviewing source text for country labeling and preparation of country artwork based on source text
Supports assigned clinical study activities in collaboration with Regional and Global Study Operations (GSO)
Assists in reviewing simple promotional and non-promotional materials
Supports regulatory product compliance activities
Assists in communicating with regulatory agencies to help fulfill local obligations
Helps the team prepare for participation in local agency interactions
Assists cross-functional colleagues under supervision to help achieve team goals

Fulltime

Sr. Business Analyst

We are currently seeking a Sr. Business Analyst - Top Secret Cleared to join our...

Location

United States , Quantico

Salary:

97391.00 - 162319.00 USD / Year

NTT DATA

Expiration Date

Until further notice

Requirements

BS/BA in Computer Science, Information Systems, Engineering, Business, Physical Science, or other technology
H.S. Diploma + 4 years additional experience equals Associate’s Degree
Associate’s Degree + 4 years additional experience equals Bachelor’s Degree
A Bachelor’s Degree may be substituted for 2 years of required experience with an Associate’s Degree or 4 years with a H.S. Diploma
Minimum 8 years of professional experience
Minimum 6 years of experience in governance, oversight and cost analysis or closely related experience including: Integrated Master Schedule (IMS), Critical Path and Schedule Risk Assessment analyses
relating software development metrics to technical achievement
and cost estimating and reporting
Minimum 3 years of Agile Software Development experience
Minimum 3 years of experience in Microsoft Office Suite (Word, Excel, and PowerPoint), Microsoft Project, and SharePoint (User)

Job Responsibility

Provide analysis and metrics of software development activities to update dashboards
Create cost estimates for future Government procurement efforts
Draft input for official data call responses within defined timelines and deadlines
Draft monthly summary reports of development and maintenance contractor activities
Draft Standardized Work in Progress (SWIP) submissions
Attend daily development contractor Agile scrum meetings and provide summary reports reflecting current progress and issues requiring Government attention
Attend all development contractor scum ceremonies and provide feedback for Government review
Coordinate risk management review meetings with Government stakeholders and maintain a risk register
Assesses risks using published Operational Risk Management (ORM) theory on government programs and projects
Drafts strategies to minimize risk likelihood and impact to the customer’s program

What we offer

medical insurance
dental insurance
vision insurance with an employer contribution
flexible spending or health savings account
life and AD&D insurance
short and long term disability coverage
paid time off
employee assistance
participation in a 401k program with company match
additional voluntary or legally-required benefits

Fulltime

Drug Safety Associate

Drug Safety Associate -Pharmacovigilance Role-Home Based-South Korea-ICON Strate...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

1 year or 1.5 years experience of related experience
Undergraduate degree or its international equivalent, preferably in life science, Nursing, Pharmacy and/or healthcare professional
Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities

Job Responsibility

Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, patient oriented programs, literature, spontaneous reports, etc
Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality
Manage reporting/submission/distribution of safety reports/updates/information(e.g. SAE, SR, SUSAR, PSUR, DSUR..etc) to local health authorities and/or clinical operations in cooperation with other clinical operation team
Provides technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects
Ensures quality and consistency across multiple projects for one client
Supports the SRM management team in the development of training courses as well as SOPs and associated documents
Participates in the Safety and Risk Management Regulatory Intelligence activities, to retrieve and maintain a global repository of regulatory safety reporting requirements
개별 사례안전보고서 (수신된 ICSR추적, 회사 또는 고객 안전 DB에 입력, 쿼리 관리)
통합안전보고서 생성지원 (약물별 정기 보고 support)
클라이언트의 라이센스 파트너에게 안전 보고서 제출

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Local Study Operations Sr Manager

Job Description

Job Responsibility

Requirements

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