Tmf Reviewer

2 weeks ago

Hyderabad, India Parexel Full time

A TMF (Trial Master File) Reviewer has proficient knowledge about Parexel or Sponsor specific Electronic Trial Master File (eTMF) and paper documents management processes and procedures.

The TMF Reviewer contributes to the assigned tasks within the project, displaying a good understanding of TMF processes, as well as efficiency, accuracy and quality. Achieves department’s overall business objectives and works closely with other levels within Records Management and under LM supervision to meet project requirements. Depending on the location and assignments, the role of a TMF Reviewer may include document processing where specifically contracted for this task, completeness checks / milestone reviews, or other activities as defined in Parexel procedures and client requirements.
** Qualifications**: Competencies, skills and abilities:

- Good computer skills including but not limited to the knowledge of Clinical Trial Systems, eTMF systems and MS-Office products such as Excel, Word
- Data Processing and analysis skills, including management of TMF documents as per the process using different systems/tools for TMF Audit/Inspection readiness
- Ensure effective, open, timely, and collaborative written and verbal communication, with internal and on occasion external stakeholders
- Ability to successfully work in a (“virtual”) team environment: In-depth understanding of how the team integrates with others in accomplishing the objectives of the area
- Able to demonstrate basic problem solving and risk management activities
- Effective time management, prioritizing multiple tasks in order to meet daily metrics, team and project objectives
- Proactive management of work quality and the assurance of consistent delivery of high-quality outcomes, minimizing wasted effort and maximizing positive results from performed work
- Able to take initiative and work independently, seeking guidance only when necessary and escalating issues as required
- Strong internal customer focus
- Offering of support and constructive feedback to project team members
- Exhibits a sense of urgency about solving problems and completing work

Knowledge and Experience:

- Preferred experience with clinical trials, or managing documentation
- Prior experience in an international environment would be advisable.
- Strong command of written and spoken English language

**Education**:

- Bachelor’s degree preferred (or relevant clinical or business equivalent)

  • Sr. Manager, TMF System Business Lead

    6 days ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Sr. Manager, TMF System Business Lead

    2 weeks ago

    Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Bristol Myers Squibb

    24 hours ago

    Hyderabad, India Bristol Myers Squibb Full time

    Working with Us: Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Sr. Manager, TMF System Business Lead

    2 weeks ago

    Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per year

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Cra

    4 days ago

    Hyderabad, Telangana, India Advity Research Full time

    **Location**: Hyderabad **Experience**: 01 - 02 **Qualifications & Other Specifics**: **Qualifications**: - B. Pharmacy / M. Pharm **Preferred Skills**: - Communication. - Time Management. - Adaptability. - Listening. - Assertive Communication. - Technical & Scientific Knowledge. - Data Integirty - Procedural Knowledge (SOP). - Regulatory...

  • Pharmacist

    4 days ago

    Hyderabad, Telangana, India Advity Research Full time

    **Location**: Hyderabad **Experience**: 01 - 02 **Qualifications & Other Specifics**: **Qualifications**: - B. Pharmacy / M. Pharm **Preferred Skills**: - Data Integrity. - Procedural Knowledge (SOP). - Technical & Scientific Knowledge. - Regulatory Awareness. - Reporting and Updating./li> - Continouing Education. **Detailed Responsibilities**: - To receive...

  • Trial Master File

    2 weeks ago

    Madhapur, Hyderabad, Telangana, India Syneos Health Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    DescriptionSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do....

  • Project Specialist

    2 weeks ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Role & responsibilities:Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.Attends, participates, prepares and...

  • Project Specialist I

    1 week ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Key Accountabilities : Project Management Plans initial set up and maintenance with Project Leader input Maintenance of selected information in the integrated project management system and working with other functions on compliance of data in the project systems Project reports, compliance...

  • Safety & PV Specialist II (Literature Review)

    4 days ago

    Madhapur, Hyderabad, Telangana, India Syneos Health Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    DescriptionSafety & PV Specialist II (Literature Review)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the...