TMF Specialist Job at Piper Companies (Bethesda)

Software Engineering Specialist

The role is accountable for ensuring that our technical deliveries realise Busin...

Location

India , Bengaluru

Salary:

Not provided

Plusnet

Expiration Date

Until further notice

Requirements

Deep knowledge on Networking domain along with solid understanding on OSS stack of Telecom including, Planning/Monitoring/Assurance
Having a strong grip on TMF standards with API based solution and Event based architecture patterns
Strong foundation on ODA Architecture patterns
Experience designing & solution and from an Engineering point of view with TMF complaint and ODA Architecture
Skilled in life cycle management of OSS tools/solutions including requirements analysis, platform selection, technical architecture design, application design & development, testing and deployment
Knowledge in various industry standard’s such as TMF, Open API
Lead and execute engineering initiatives to ensure the network cloud platform is easily consumable by products and solutions that are built on top of the platform
and at the sametime, is compliant with information security standards
Implement governance and controls to monitor and manage consumption and compliance with security and other standards
Implement and publish APIs for clients to consume platform services in a consistent way

Job Responsibility

Role implements the defined architectural roadmap for the Assurance Area for the following: Fault Management
Resource Management
Incident Management
Change Management
Role involves defining and implementing the roadmap for Transformation of IT, DataCenter and Network Cloud applications in Service and Problem management
Manage, Engineer, Architect, Develop and Maintain applications in Network Management, OSS and FCAPS space

Fulltime

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

Study Start-Up Specialist

The Study Start-Up Specialist supports project teams by executing study start-up...

Location

Germany , Mainz

Salary:

Not provided

TFS HealthScience

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferred
minimum 1–3 years of relevant clinical research experience
Good understanding of ICH/GCP, local regulatory requirements, SOPs, and corporate standards
Experience with investigator start-up documents and investigative sites is preferred
Strong communication, organizational, and cross-functional teamwork skills
Ability to manage multiple priorities in a fast-paced environment
strong computer skills

Job Responsibility

Execute end-to-end start-up activities for assigned studies (country/region level), including feasibility, site identification, site initiation support, and start-up progress reporting, ensuring timelines, scope, and compliance with ICH/GCP, SOPs, protocols, and regulatory requirements
Collect, review, approve, track, and quality-check all regulatory and investigator documents
prepare and manage IEC/IRB submissions, amendments, regulatory fees, and collaborate with Regulatory on Health Authority/Competent Authority notifications
Lead local adaptation and documentation of Informed Consent Forms
ensure contracts are fully executed, regulatory approvals are granted, IP release is authorized, and all conditions for site activation are fulfilled
Maintain complete, accurate, and timely start-up documentation in CTMS, TMF, SMF, and central repositories
ensure proper submission of materials to TMF
support SSU Lead/PM with project set-up, Greenlight activities, and site activation processes
Support audits and inspections
provide feedback on site performance

What we offer

competitive compensation package
comprehensive benefits
opportunity for personal and professional growth in a rewarding environment

Senior Study Specialist, Global Study Operations

The Sr. Study Specialist (SS) significantly contributes to or leads tasks relate...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS or higher in nursing, life or health sciences is preferred
Industry or relevant experience in lieu of education is considered
Experience in a biotechnology or pharmaceutical company
Experience in oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Proficient knowledge and experience in Agility and Proactivity, Leadership, Communication and Collaboration, Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge

Job Responsibility

Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life-cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance

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

HR Business Partner

Meta is seeking an HR Business Partner to support our tech and/or business organ...

Location

United States

Salary:

152000.00 - 220000.00 USD / Year

New

Criminal justice social worker

The Criminal Justice Social Work team in Edonburgh is seeking a dedicated and mo...

Location

United Kingdom , Edinburgh

Salary:

Not provided

Randstad

Expiration Date

March 09, 2026

Requirements

Qualified Social Worker
SSSC registered in the Social Work part of the register
LSCMI trained

Job Responsibility

Conduct comprehensive assessments and develop tailored support plans for individuals referred by the courts
Manage a caseload of individuals on probation or community sentences, providing one-on-one support and facilitating group work
Work collaboratively with law enforcement, health services, and community organisations to support individuals in achieving their goals
Prepare written reports for the courts, parole boards, and other relevant agencies
Provide advice, advocacy, and emotional support to clients, promoting their well-being and addressing any issues or barriers
Maintain accurate and up-to-date records in line with Edinburgh City Council's policies and data protection standards

What we offer

Flexible hours
Competitive rate of pay
Free training to keep up to date with your Continuous Professional Development
Contributory pension
Referral scheme - receive £300 in vouchers (subject to Ts and Cs)
Help with sourcing accommodation and travel, if required
Dedicated Randstad consultant - one point of contact
Weekly payroll
Support with finding accommodation

Fulltime

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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