TMF SWAT Manager

2 weeks ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

- Act as CDGM point of contact for assigned portfolio of In-Licensing / Out-Licensing / Acquisition / Divestment Projects, collaborating with key stakeholders with CDGM teams, Development Informatics, Legal, Development Quality Assurance and Global Project Teams.
- Lead and/or Contribute to the development of TMF Transition Plans and ensure the successful transitions of TMF (paper and electronic) documentation outside of Novartis in support of out-licensing and divestment projects, and into Novartis in support of in-licensing and acquisition projects.
- Develop and maintain paper and electronic document processes & standards relating to BD&L projects and Out licensing activities, in compliance with internal and external requirements & regulations
- Identify and communicate risks/trends/patterns relating to TMF, BD&L projects, Out licensing activities and work with key stakeholders to define and implement pragmatic remediations.
- Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
- Serves as Subject Matter Expert on TMF transition related training materials, formal and informal processes and tracking tools for TMF transition oversight activities in collaboration with CDM Process team and other key stakeholders
- Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.
- Identify and implement improvements to document management processes to improve quality of TMF integration activities. May act as business lead for innovation projects to enhance integration processes.
- Supports the TMF Integration Lead with respect to forecasting and planning of B&&L projects.

Relevant Experience:

- Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
- Demonstrated success in planning and executing cross functional projects.
- Strong influencing and presentation skills. Ability to communicate effectively at all levels.
- High organisational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
- Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.

Languages :

- English.

  • TMF Specialist

    2 weeks ago

    Hyderabad, Telangana, India Tilda Research Full time

    We're looking for a detail-obsessed TMF professional to own eTMF completeness, accuracy, and inspection readiness across assigned studies. You'll run periodic/milestone reviews in Veeva Vault , identify and resolve gaps (including co-dependencies), and partner closely with Study Teams and the TMF Lead to keep the file audit-ready at all times. If ALCOA+ and...

  • Only 24h Left) TMF Specialist

    2 weeks ago

    Hyderabad, Telangana, India Tilda Research Full time

    We're looking for a detail-obsessed TMF professional to own eTMF completeness, accuracy, and inspection readiness across assigned studies. You'll run periodic/milestone reviews in Veeva Vault, identify and resolve gaps (including co-dependencies), and partner closely with Study Teams and the TMF Lead to keep the file audit-ready at all times. If ALCOA+ and...

  • Senior Electronic Document Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeDocument Full time ₹ 90,00,000 - ₹ 1,50,00,000

    Senior Electronic Document Specialist Role OverviewWe are seeking an experienced and detail-driven professional to oversee the accuracy, integrity, and inspection readiness of electronic Trial Master Files (eTMFs) across assigned studies.Main Responsibilities:eTMF Reviews & ReadinessPerform comprehensive completeness checks in Veeva Vault, with cross-check...

  • Specialist, Regulatory

    1 week ago

    Hyderabad, Telangana, India Tilda Research Full time

    We're looking for a detail-obsessed TMF professional to own eTMF completeness, accuracy, and inspection readiness across assigned studies. Maintain inspection readiness for allocated studies; Quality, Compliance & Metadata Validate document types, properties, indexing, and scanning quality against TMF readiness criteria and reference standards. escalate ...

  • Electronic Trial Master File Operations Expert

    1 week ago

    Hyderabad, Telangana, India beBeeTmf Full time ₹ 6,00,000 - ₹ 10,00,000

    TMF SpecialistThis is a highly rewarding role for a detail-obsessed professional with expertise in TMF/eTMF operations. The ideal candidate will own eTMF completeness, accuracy, and inspection readiness across assigned studies.Main Responsibilities:eTMF Reviews & Readiness The successful candidate will perform comprehensive completeness checks (periodic &...

  • eTMF Regulatory Compliance Specialist

    2 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 8,00,000

    TMF Specialist - Regulatory ComplianceWe are seeking a meticulous TMF professional to ensure the completeness, accuracy, and inspection readiness of assigned studies across allocated projects.Maintain inspection readiness for allocated studies; ensuring quality, compliance, and metadata consistency.Validate document types, properties, indexing, and scanning...

  • Telecommunications Solution Strategist

    2 weeks ago

    Hyderabad, Telangana, India beBeeSolution Full time US$ 7,50,000 - US$ 10,50,000

    About the Role:We are seeking a highly skilled Telecommunications Solution Strategist to join our team. In this role, you will be responsible for acting as a primary customer interface and bridge the offshore team with the customer, meeting customer expectations.Your responsibilities will include capturing business requirements, analysis, solutioning, and...

  • OSS Solution Designer Position

    6 days ago

    Hyderabad, Telangana, India beBeeSolutionDesigner Full time ₹ 20,00,000 - ₹ 25,00,000

    Lead Solution StrategistOptimize Business Outcomes through Expert OSS Solution Design.Job Description:We seek an experienced Lead Solution Strategist to design and implement cutting-edge OSS solutions that meet the evolving needs of our clients. As a key member of our team, you will be responsible for capturing business requirements, analyzing solutions, and...

  • Document Management Specialist

    2 weeks ago

    Hyderabad, Telangana, India beBeeClinical Full time ₹ 30,00,000 - ₹ 40,00,000

    Clinical Document ManagementJob Overview:We are seeking a skilled Clinical Document Management specialist to drive the implementation of CDGM initiatives and projects.Key Responsibilities:Drive the planning and execution of migrations to and from enterprise clinical eDMS, aligning with business, compliance, and operational requirements.Partner with...

  • Opening For SME

    3 days ago

    Hyderabad, Telangana, India Cognizant Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Roles & Responsibilities.Execute predictive model-based order fallout to proactively address and resolve complex service order issues. Act as a single point of contact for resolving critical order exceptions that cannot be handled by standard dispatch or back-office teams. Liaise with field technicians to gather on-site information and provide technical...