Local Study Operations Sr Manager Job at Amgen (Milan)

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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

Senior Clinical Research Associate II - FSP

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

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

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 to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

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

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

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

Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - East Coast. ICON plc is a world-...

Location

United States , Atlanta; Texas; Maryland; Missouri; Tennessee; North Carolina; Illinois; Ohio; Florida; Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution
a licensed health care professional (i.e. registered nurse) or equivalent work experience required
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by sponsor's SOPs
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution

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

Sr Manager, Environmental

Develops and implements programs to ensure that environment regulatory obligatio...

Location

United States , Tyler

Salary:

Not provided

Delek US

Expiration Date

Until further notice

Requirements

4 year / Bachelor's Degree (Required)
Two (2) or more years Management experience (Required)
Eight (8) or more years Experience in refining industry (Required)
Environmental
Federal, State and Local Environmental Regulations
Remediation
Health & Safety Management
Process Safety Management
Analysis
Relationship Management

Job Responsibility

Develops and implements programs to ensure that environment regulatory obligations are fulfilled in a cost-effective manner and that environmental risks are effectively managed at the refinery (facility/asset)
Analyzes and maintains detailed records of pollutant concentrations in air, water, plant and soil samples
Conducts periodic monitoring for effectiveness of pollution prevention and water minimization programs in coordination with Corporate Environmental Management. and technical guidance
Conducts research on the degradation of pollutants in the environment, including streams, sediments and groundwater
Maintains detailed records and prepares related reports and studies for submission to regulatory agencies
Responsible for environmental regulation analysis
Provides timely regulatory update and develop strategies and programs for facility implementations to ensure timely compliance with federal and state rules
Represents company in dealing with Federal and Texas environmental regulatory agencies to ensure compliance planning and strategies
pro-actively develops trusting relationships with regulatory agencies as appropriate
Provides support for Refinery capital projects, operation and maintenance for environmental emission control devices

What we offer

up to a 10% match on 401K on your hire start, with a vesting timeline of only one year
medical benefits that start on day one with a 30% premium rebate annually
access to the Calm app for FREE
performance management program, you can earn additional annual incentives as you set and achieve goals

Fulltime

Sr Associate Regulatory Affairs

The Local Regulatory Representative (Sr. Associate) is assigned to one or more A...

Location

South Korea , Seoul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

At least 5 years of directly related experience
Business-level proficiency in Korean and English is required
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
Understanding of drug development
Under general supervision interact with local health and regulatory authorities for routine matters
Demonstrate ability to work in teams
Ability to understand and communicate scientific/clinical information

Job Responsibility

Assist in aligning local regulatory requirements with Amgen’s corporate standards
Provide national/regional input to and execute regulatory strategies
Plan and manage local regulatory submissions
Ensure local labels are developed and maintained
Act as the point of contact with regulatory agencies
Plan and manage clinical trial applications through CRO
Manage CRO work invoice and participate in global network
Work as a point of contact and oversight for Global Regulatory Affairs & Strategy
Contributes for the filing plan
Executes the filing plan

Medical Science Liaison or Senior Medical Science Liaison

The Skeletal Conditions (SC) Medical Science Liaison (MSL) / Senior MSL is a reg...

Location

United States

Salary:

178200.00 - 267400.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life or health sciences
Advanced degree (MS, doctoral level) preferred
3 or more years of relevant experience in clinical and 1 or more year as an MSL preferred
Experience in rare genetic diseases, ACH and/or Skeletal Conditions therapy preferred
Experience in product launch, development, and execution preferred
Knowledge of regulations impacting Medical Affairs and field activities in the pharmaceutical industry
Excellent oral and written communication, organization, and people skills
Proven record as a team player
Project management understanding and experience
Ability to effectively work in a virtual environment and knowledge of virtual and collaborative systems

Job Responsibility

Execute SC medical MSL plan and tactics within assigned territory
Development and periodic refinement of an approved MSL Territory Plan
Provide education relative to disease state and BioMarin products across product lifecycle to health care providers
Serve as a medical/scientific resource through answering unsolicited medical questions
Engage in scientific exchange and provide feedback on emerging clinical/competitive trends
Identify, document, discuss and communicate insights to internal stakeholders
Maintain clinical and technical expertise in relevant therapeutic area
Partner with medical and research groups and compliantly collaborate with commercial team
Provide support to BioMarin clinical trials including site identification and evaluation, recruitment, investigator meetings, external expert identification, and study management
Support clinical operations in identifying and interacting with potential investigators

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

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Local Study Operations Sr Manager

Job Description

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