TMF Specialist Job at Piper Companies (Bethesda)

Regional Mobile Chef Manager

Step away from the same kitchen every day. As a Relief Chef Manager with Caterpl...

Location

United Kingdom , Edinburgh

Salary:

30000.00 GBP / Year

Elior UK

Expiration Date

Until further notice

Requirements

Senior chef experience
Calm, organised and confident under pressure
A genuine passion for customer service
Strong kitchen management and people leadership
A positive, solutions-focused approach
TMF experience helpful, though training provided
Must be flexible
Hold a full valid UK driving licence
Have your own reliable transportation

Job Responsibility

Cover planned and unplanned absence across multiple Caterplus locations
Support teams during busy periods or transition
Bring consistency, standards and leadership wherever you go
Keep kitchens running safely, efficiently and to Caterplus standards
Act as the regional specialist for Textured Modified Foods (TMF), delivering training and best practice
Build strong relationships with managers and operations teams across the region
Role model high standards in H&S, food safety and compliance

What we offer

Free, tasty meals
Flexible working
28 days of holiday (31 after two years)
Leave for life’s important moments
Paid volunteering days
Career development and learning opportunities
Mental health support and wellbeing perks
Pension schemes and life assurance
Exclusive discounts on entertainment, leisure, and travel
Car allowance

Fulltime

Clinical Study Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Warren, NJ or Cambridge, MA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

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

Field Technical Support - NonStop Servers

Field Technical Support role providing onsite technical services for HPE NonStop...

Location

India , Mumbai

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Engineering, or related field
5+ years of experience supporting HPE NonStop systems in enterprise environments
Strong understanding of NonStop OS, Guardian, OSS, TCP/IP, and related subsystems
Experience with NonStop utilities such as SCF, FUP, TMF, EMS, and PATHWAY
Familiarity with ITIL processes (Incident, Problem, Change Management)
Excellent troubleshooting, communication, and customer service skills
HPE ASE/MASE – NonStop Systems certification preferred
ITIL Foundation or higher certification preferred
Individual contributors at Specialist job-level for a minimum of three years
Experience with HPE Nonstop, HPE Unix, or Linux operating system

Job Responsibility

Provide Level 2/3 technical support for incidents related to HPE NonStop hardware and software
Troubleshoot and resolve complex system issues, escalating to engineering teams when necessary
Perform root cause analysis and implement permanent fixes to prevent recurrence
Apply advanced technical knowledge to operate one or more technology areas
Perform ongoing health checks, performance tuning, and capacity planning for HPE NonStop systems
Apply patches, firmware updates, and software upgrades in coordination with customer change management processes
Implement approved changes to system configurations, ensuring minimal disruption to business operations
Serve as a trusted advisor to customers, providing technical guidance and recommendations
Participate in customer review meetings and contribute to continuous service improvement initiatives
Work closely with HPE internal teams, including engineering, product support, and account management

What we offer

Health & Wellbeing benefits
Personal & Professional Development programs
Unconditional Inclusion environment
Comprehensive suite of benefits supporting physical, financial and emotional wellbeing
Career development programs
Flexible work arrangements

Fulltime

GCP QA Consultant

Proclinical is seeking a GCP QA Consultant to support quality assurance activiti...

Location

Germany , Berlin

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong knowledge of ICH-GCP guidelines and regulatory requirements
Experience in quality assurance for clinical trials, particularly in phase 2-3 studies
Proficiency in risk management and quality oversight processes
Ability to manage and maintain TMF documentation and ensure inspection readiness
Skilled in identifying deviations, implementing corrective actions, and driving process improvements
Excellent communication and collaboration skills to work with cross-functional teams and external partners
Familiarity with Clinical Trial Agreements, site feasibility, and activation processes
Leadership and mentoring abilities to guide junior team members

Job Responsibility

Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans
Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking
Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements
Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings
Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements
Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events
Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans
Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes
Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready

Fulltime

Veeva Clinical Business Administration Specialist

Empower clinical teams by optimizing the Veeva Vault systems that keep trials ru...

Location

United States , Boston

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong oral and written communication skills
excellent organizational abilities and attention to detail
ability to work both independently and collaboratively in a fast-paced environment
familiarity with clinical trial processes, ICH-GCP guidelines, and essential documents
critical thinking and problem-solving skills
proficiency in Microsoft Office applications
knowledge of GXP systems in the pharmaceutical or CRO industry, particularly CTMS or related systems
understanding of computer system validation and system lifecycles
experience with Veeva Vault Clinical eTMF and CTMS systems
database management and reporting experience

Job Responsibility

Develop and maintain Veeva Vault reports and dashboards, ensuring clear documentation for user understanding
collaborate with the Change Management team to draft system training materials, including quick reference guides and presentations
provide end-to-end user support, including troubleshooting, technical assistance, and analysis of request trends
manage business process-driven values, metadata, controlled vocabularies, and picklists
liaise with internal and external IT teams to address bugs, discuss functionality, and implement best practices
identify opportunities for process improvements and system enhancements, including performing system health checks and gathering user feedback
support PQ execution and participate in training sessions, office hours, and knowledge-sharing events
manage CTMS requests, such as study record creation, team roster updates, and troubleshooting
communicate new release information to users in an accessible and efficient manner
oversee TMF requests, including monitoring document integration metrics, conducting post-migration quality checks, and reviewing audit trails

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

New

Healthcare Assistant & Lead Healthcare Assistant

Are you passionate about supporting older people and making a meaningful differe...

Location

Ireland , Cork

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience in elderly care is desirable but not essential (training may be provided)
QQI Level 5 in Healthcare Support or equivalent is an advantage
A caring, patient and respectful approach to supporting older people
Ability to work flexible shifts including days, nights, and weekends
Strong commitment to resident safety, dignity and wellbeing
Applicants must have legal entitlement to work in Ireland

Job Responsibility

Deliver person-centred care to residents with dignity and respect
Support residents with activities of daily living where required
Encourage independence and social engagement
Maintain a clean, safe and comfortable living environment
Build positive relationships with residents, families, and colleagues
Follow all health, safety and safeguarding procedures
Assist with compliance processes, inspections, and quality standards
Lead Healthcare Assistants will also assist in guiding care teams, supporting best practice, and helping maintain high standards of care delivery

What we offer

Flexible working hours to support work–life balance
Local employment opportunities within the Douglas, Cork area
Competitive rates of pay in line with experience and role
Supportive team environment with ongoing training and development
Employee wellbeing initiatives
Uniform provided
Free on-site parking
Meals provided while on duty

New

Bakery Team Member

Join us to "Change Hospitality For Good". Here at the Cornish Bakery, we want to...

Location

United Kingdom , Falmouth

Salary:

8.05 - 12.80 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Eligible to live and work in the UK

Job Responsibility

Make the World’s Best Coffee
Deliver Outstanding Customer Service
Prepare Award Winning Food
Maintain High standards within the Bakery
Be part of a Team who strive to Aim Higher at all times

What we offer

50% discount on food and drink
Pasty Perks – bespoke reward system offering discounts and savings on favourite brands
Financial well-being benefit through Stream – save directly from wages into a high interest savings account or access wages before pay-day
Employer funded health and wellbeing services with access to a 24/7 GP line, Employee Assistance Program and discounted gym memberships
Paid birthday day off
Member of the shareholder fund (service dependent)
Team social events with in-bakery incentives
Up to 28 days of holiday (including bank holidays), pro rata if necessary

TMF Specialist

Piper Companies

Location:
United States , Bethesda

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 23, 2026

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