Clinical Data Manager II/III Job at GRUPA NEUCA

Senior CRA - Ph 2/3

A growing biotechnology organization is seeking an experienced Senior CRA to sup...

Location

United States

Salary:

75.00 - 90.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences or related discipline
4+ years of in-house CRA experience within a sponsor or biotech environment
Experience supporting global clinical trials
Phase II/III trial experience required
Demonstrated experience in site oversight and vendor management
Experience contributing to clinical study management activities

Job Responsibility

Support the Global Clinical Study Lead / Senior Clinical Trial Manager in the operational management of Phase II/III trials from study start-up through closeout
Provide oversight of CRO monitoring activities, ensuring quality, protocol compliance, and GCP adherence
Act as a key point of escalation for site-related operational issues
Contribute to protocol development, study design discussions, and operational feasibility
Manage operational aspects of investigative site relationships and study execution
Oversee external vendors (IRT, eCOA, cardiac safety, patient reimbursement, etc.) and support vendor performance management
Participate in vendor selection activities, including RFP review and bid defenses
Support development and maintenance of study timelines, operational plans, and budgets
Contribute to the development of key study documents and site-facing materials
Support CRF design, UAT, edit check review, and data quality oversight

What we offer

medical
dental
401(k)
direct deposit
commuter benefits

Senior Software Engineer

The Senior Software Engineer (R&D) will be responsible for developing software t...

Location

United States , Burnsville

Salary:

110000.00 - 140000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in computer science, software engineering, or related technical field
advanced degree preferred
Minimum of 5 years of development experience in the medical device industry
Strong proficiency in Java, C/C++, RTOS, and microcontrollers for embedded systems
Experience with FDA 510(k), PMA, EU MDR technical documentation and cybersecurity standards, or post market surveillance
Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
Strong analytical and problem-solving skills, and comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering

Job Responsibility

Develops software used in Imricor products, ranging from firmware to User Interface
Works closely with hardware, software, quality, regulatory, and clinical teams to define requirements and drive product innovation
Develops software following best practices for reliability, safety, and scalability and in full compliance with IEC 62304 and FDA Class II/III device requirements
Develops automated tests, unit tests, integration tests, and supports verification and validation (V&V) activities
Supports design transfer, manufacturing, and posts market software updates
Analyzes field data, customer feedback, and defect trends to drive continuous improvement
Generates and maintains documentation including software requirements, architecture, design specifications, traceability, and risk analysis
Ensures products are developed per Imricor’s Quality Management System
Ensures that projects are completed per Imricor’s Design Control processes
Ensures product development timeline goals are being met

What we offer

Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits

Fulltime

Specialist Contract Development & Manufacturing

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

111577.00 - 150507.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Manufacturing experience
Associate’s degree and 8 years of Manufacturing experience
Bachelor’s degree and 4 years of Manufacturing experience
Master’s degree and 2 years of Manufacturing experience
Doctorate degree
Bachelor’s in Business Administration, Engineering, or Science-related field
5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
2+ years of project management experience leading multi-functional and/or multi-location team
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

Job Responsibility

Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network
Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting
inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc
Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records
Report contract site performance metrics to site lead
identify improvement opportunities for site performance
daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team
Follow-up and track activities in a department-wide project from conception to implementation and close-out
Manage timeline and highlight risks of transfer team activities
coordinate risk management activities as part of transfer

What we offer

A 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
Flexible work models where possible

Fulltime

Clinical Genomics Scientist, Oncology

Join a team of brilliant, passionate innovators who wake up every day determined...

Location

United States

Salary:

100.00 USD / Hour

BillionToOne

Expiration Date

Until further notice

Requirements

Ph.D. in Human Genetics, M.S. in Genetic Counseling, or related field
2+ years of experience in somatic variant interpretation based on ACMG/AMP guidelines in a clinical setting (alternatively, 1+ years of germline variant interpretation and 1+ years of somatic variant interpretation experience)
Hands-on experience working with human mutation databases (COSMIC, ClinVar, OncoKB), functional annotation sources (dbSNP), and genome browsers (UCSC)
Familiarity with IGV and BAM file analysis and data-minded willingness to learn to use basic bioinformatics tools, with technically minded insights
Knowledge of cancer somatic mutation and signaling pathways (e.g., which mutations have FDA approved drugs, Phase II/III clinical trials, which mutations are considered “hot targets” for drug development, etc.)
Exceptional attention to detail to follow highly detailed SOPs and strong organizational skills to track and manage clinical reporting and product improvement projects
Excellent communication skills and ability to work collaboratively with cross-functional teams
Ability to work on Saturday and/or Sunday, in addition to hours during the week.

Job Responsibility

Somatic variant interpretation and data review: Perform somatic-based variant interpretation, diving into the literature and databases to classify variants and match treatments for reporting, performing verification as required with BAM file analysis
Clinical report drafting: Carefully draft reports for each requisition primarily using in-house reporting API, working closely with the engineering and QA teams on reporting, and the laboratory directors on report language
Content curation: Contribute to curation of gene-level content such as domain and critical residue curation
Contribute to oncology R&D: Work closely with the R&D team to help with somatic oncology based projects, providing expertise on variant interpretation, biological pathways/mechanisms, and other gene/variant-level reviews and analyses.

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
The ability to indirectly or directly change the lives of hundreds of thousands patients

Parttime

Clinical Genomics Scientist, Oncology

BillionToOne is looking for a Clinical Genomics Scientist, Oncology to help driv...

Location

United States , Menlo Park

Salary:

158401.00 - 179521.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

Ph.D. in Human Genetics, M.S. in Genetic Counseling, or related field
2+ years of experience in somatic variant interpretation based on ACMG/AMP guidelines in a clinical setting (alternatively, 1+ years of germline variant interpretation and 1+ years of somatic variant interpretation experience)
Hands-on experience working with human mutation databases (COSMIC, ClinVar, OncoKB), functional annotation sources (dbSNP), and genome browsers (UCSC)
Familiarity with IGV and BAM file analysis and data-minded willingness to learn to use basic bioinformatics tools, with technically minded insights
Knowledge of cancer somatic mutation and signaling pathways (e.g., which mutations have FDA approved drugs, Phase II/III clinical trials, which mutations are considered “hot targets” for drug development, etc.)
Exceptional attention to detail to follow highly detailed SOPs and strong organizational skills to track and manage clinical reporting and product improvement projects
Excellent communication skills and ability to work collaboratively with cross-functional teams
Operationally-defined flexible schedule, including weekends, as dictated by clinical reporting needs

Job Responsibility

Somatic variant interpretation and data review: Perform somatic-based variant interpretation, diving into the literature and databases to classify variants and match treatments for reporting, performing verification as required with BAM file analysis
Clinical report drafting: Carefully draft reports for each requisition primarily using in-house reporting API, working closely with the engineering and QA teams on reporting, and the laboratory directors on report language
Somatic mutation interpretation and reporting policy development: Work closely with lab directors, R&D, medical, and other related functions to develop and modify the somatic interpretation SOPs in accordance with ACMG/AMP guidelines, and the latest published literature
Content curation: Contribute to curation of gene-level content such as domain and critical residue curation
Molecular tumor board: Serve as a subject matter expert in consulting with the medical science liaison team, and presenting in molecular tumor boards to facilitate knowledge sharing
Contribute to oncology R&D: Work closely with the R&D team to help with somatic oncology based projects, providing expertise on variant interpretation, biological pathways/mechanisms, and other gene/variant-level reviews and analyses

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

New

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

New

K Kitchen Representative

The position includes, but is not limited to, the following essential job duties...

Location

United States , New Albany

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

New

K Kitchen Representative

Location

United States , Decatur

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

Select Country

Clinical Data Manager II/III

Job Responsibility

Requirements

Nice to have

What we offer

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