Specialist
Bristol-Myers Squibb
Specialist
Job Description
Manage the signing of clinical trial documentation such as powers of attorney, expected to be able to coordinate many signing at the same time. Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions. Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs. Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications. Ensure consistency of the Clinical Trial application across projects, studies and countries. Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/manager role, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations. Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations. Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates. Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements. Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT. Expected to be able to coordinate updates within a Program. Support continuous improvement and compliance initiatives Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT. Support implementation of the EU CT REG Portal from Feb 2022 Supporting People with Disabilities Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities. Communicates questions and issues as they arise with possible solution. Supports other functions as appropriate. Participates in study team meetings. Works with supervision.
About the Role/Company
- The company focuses on clinical trial management and regulatory submissions
- The department is involved in Global Study Management - Clinical Trials (GSM-CT)
Key Responsibilities
- Manage the signing of clinical trial documentation such as powers of attorney
- Coordinate multiple signings simultaneously
- Support the Submission Senior Specialist/Manager in CTA preparation activities for initial filings, start-up activities, protocol amendments, end of trials, and CSR distributions
- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
- Prepare data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
- Ensure consistency of the Clinical Trial application across projects, studies, and countries
- Actively participate in Program/Study level CTA Tracking Meetings led by Senior Specialist/Manager
- Liaise with country offices and central team to ensure compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
- Comply with the use and maintenance of planning & tracking tools (e.g., Veeva) to generate reports and track CTA content and associated dates
- Escalate observed trends and issues to study teams and GSM-CT senior roles that may impact timely and successful study approval and execution
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
- Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
- Coordinate updates within a Program
- Support continuous improvement and compliance initiatives
- Utilize technology effectively to support the clinical trial application submission process
- Generate reports and track CTA content and associated dates using CTMS, Tracking systems, and Excel trackers
- Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
- Support implementation of the EU CT REG Portal from Feb 2022
- Communicate questions and issues as they arise with possible solutions
- Support other functions as appropriate
- Participate in study team meetings
- Work with supervision
Required Qualifications
- Bachelor's degree in a relevant field
- Experience in clinical trial documentation and regulatory submissions
- Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications
Preferred Qualifications
- Advanced degree in a relevant field
- Experience with EU CT REG Portal
- Familiarity with Veeva and other tracking systems
Skills Required
- Strong coordination and multitasking abilities
- Proficiency in using CTMS, Tracking systems, and Excel trackers
- Effective communication skills
- Ability to work with supervision
- Problem-solving skills
Additional Requirements
- Ability to work with country offices and central teams
- Compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 900,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong coordination and multitasking abilitiesintermediate
- Proficiency in using CTMS, Tracking systems, and Excel trackersintermediate
- Effective communication skillsintermediate
- Ability to work with supervisionintermediate
- Problem-solving skillsintermediate
Required Qualifications
- Bachelor's degree in a relevant field (experience)
- Experience in clinical trial documentation and regulatory submissions (experience)
- Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications (experience)
Preferred Qualifications
- Advanced degree in a relevant field (experience)
- Experience with EU CT REG Portal (experience)
- Familiarity with Veeva and other tracking systems (experience)
Responsibilities
- Manage the signing of clinical trial documentation such as powers of attorney
- Coordinate multiple signings simultaneously
- Support the Submission Senior Specialist/Manager in CTA preparation activities for initial filings, start-up activities, protocol amendments, end of trials, and CSR distributions
- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
- Prepare data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
- Ensure consistency of the Clinical Trial application across projects, studies, and countries
- Actively participate in Program/Study level CTA Tracking Meetings led by Senior Specialist/Manager
- Liaise with country offices and central team to ensure compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
- Comply with the use and maintenance of planning & tracking tools (e.g., Veeva) to generate reports and track CTA content and associated dates
- Escalate observed trends and issues to study teams and GSM-CT senior roles that may impact timely and successful study approval and execution
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
- Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
- Coordinate updates within a Program
- Support continuous improvement and compliance initiatives
- Utilize technology effectively to support the clinical trial application submission process
- Generate reports and track CTA content and associated dates using CTMS, Tracking systems, and Excel trackers
- Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
- Support implementation of the EU CT REG Portal from Feb 2022
- Communicate questions and issues as they arise with possible solutions
- Support other functions as appropriate
- Participate in study team meetings
- Work with supervision
Tags & Categories
Specialist
Bristol-Myers Squibb
Specialist
Job Description
Manage the signing of clinical trial documentation such as powers of attorney, expected to be able to coordinate many signing at the same time. Provide support to the Submission Senior Specialist/Manager in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions. Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs. Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications. Ensure consistency of the Clinical Trial application across projects, studies and countries. Actively participate in Program/Study level CTA Tracking Meetings, led by Senior Specialist/manager role, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations. Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations. Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates. Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements. Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT. Expected to be able to coordinate updates within a Program. Support continuous improvement and compliance initiatives Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT. Support implementation of the EU CT REG Portal from Feb 2022 Supporting People with Disabilities Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities. Communicates questions and issues as they arise with possible solution. Supports other functions as appropriate. Participates in study team meetings. Works with supervision.
About the Role/Company
- The company focuses on clinical trial management and regulatory submissions
- The department is involved in Global Study Management - Clinical Trials (GSM-CT)
Key Responsibilities
- Manage the signing of clinical trial documentation such as powers of attorney
- Coordinate multiple signings simultaneously
- Support the Submission Senior Specialist/Manager in CTA preparation activities for initial filings, start-up activities, protocol amendments, end of trials, and CSR distributions
- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
- Prepare data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
- Ensure consistency of the Clinical Trial application across projects, studies, and countries
- Actively participate in Program/Study level CTA Tracking Meetings led by Senior Specialist/Manager
- Liaise with country offices and central team to ensure compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
- Comply with the use and maintenance of planning & tracking tools (e.g., Veeva) to generate reports and track CTA content and associated dates
- Escalate observed trends and issues to study teams and GSM-CT senior roles that may impact timely and successful study approval and execution
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
- Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
- Coordinate updates within a Program
- Support continuous improvement and compliance initiatives
- Utilize technology effectively to support the clinical trial application submission process
- Generate reports and track CTA content and associated dates using CTMS, Tracking systems, and Excel trackers
- Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
- Support implementation of the EU CT REG Portal from Feb 2022
- Communicate questions and issues as they arise with possible solutions
- Support other functions as appropriate
- Participate in study team meetings
- Work with supervision
Required Qualifications
- Bachelor's degree in a relevant field
- Experience in clinical trial documentation and regulatory submissions
- Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications
Preferred Qualifications
- Advanced degree in a relevant field
- Experience with EU CT REG Portal
- Familiarity with Veeva and other tracking systems
Skills Required
- Strong coordination and multitasking abilities
- Proficiency in using CTMS, Tracking systems, and Excel trackers
- Effective communication skills
- Ability to work with supervision
- Problem-solving skills
Additional Requirements
- Ability to work with country offices and central teams
- Compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
Locations
- Hyderabad TS, India
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
300,000 - 900,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong coordination and multitasking abilitiesintermediate
- Proficiency in using CTMS, Tracking systems, and Excel trackersintermediate
- Effective communication skillsintermediate
- Ability to work with supervisionintermediate
- Problem-solving skillsintermediate
Required Qualifications
- Bachelor's degree in a relevant field (experience)
- Experience in clinical trial documentation and regulatory submissions (experience)
- Proficient knowledge of Regulatory Submissions and package content for non-US clinical trial applications (experience)
Preferred Qualifications
- Advanced degree in a relevant field (experience)
- Experience with EU CT REG Portal (experience)
- Familiarity with Veeva and other tracking systems (experience)
Responsibilities
- Manage the signing of clinical trial documentation such as powers of attorney
- Coordinate multiple signings simultaneously
- Support the Submission Senior Specialist/Manager in CTA preparation activities for initial filings, start-up activities, protocol amendments, end of trials, and CSR distributions
- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs
- Prepare data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications
- Ensure consistency of the Clinical Trial application across projects, studies, and countries
- Actively participate in Program/Study level CTA Tracking Meetings led by Senior Specialist/Manager
- Liaise with country offices and central team to ensure compliance with study timelines, BMS SOPs, worldwide regulatory guidelines, and regulations
- Comply with the use and maintenance of planning & tracking tools (e.g., Veeva) to generate reports and track CTA content and associated dates
- Escalate observed trends and issues to study teams and GSM-CT senior roles that may impact timely and successful study approval and execution
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements
- Support initiatives for innovation and simplification in processes to improve support to study teams and GSM-CT
- Coordinate updates within a Program
- Support continuous improvement and compliance initiatives
- Utilize technology effectively to support the clinical trial application submission process
- Generate reports and track CTA content and associated dates using CTMS, Tracking systems, and Excel trackers
- Contribute to other requirements as appropriate to allow proper functioning of the GSM-CT
- Support implementation of the EU CT REG Portal from Feb 2022
- Communicate questions and issues as they arise with possible solutions
- Support other functions as appropriate
- Participate in study team meetings
- Work with supervision
Tags & Categories