Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Manager, Clinical Trial Disclosure and Transparency
1020 First Avenue King of Prussia, PA 19406 US
Posted: 11/10/2023
2023-11-10
2023-12-22
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 591252
Is job remote?: No
Country: United States
Job Description
Target PR Range: 50-70/hr
*Depending on experience
Position Purpose:
The Manager, Clinical Trial Disclosure and Transparency is responsible for executing disclosure and transparency activities as directed, including the redaction and anonymization of clinical trial documents required for public disclosure in compliance with regulatory requirements and policy and processes. This role will partner with internal stakeholders and external vendors for the planning, initiation and delivery of redacted/anonymized documents required for EU Clinical Trial Applications according to the EU Clinical Trial Regulation 536/2014 and Health Authority transparency submissions (eg EMA Policy 0070, Health Canada PRCI).
The incumbent will also contribute to the development and maintenance of procedures and standards that will support current and future global clinical trial disclosure requirements.Â
This role operates within a global matrix organization and is responsible for active collaboration with teams and stakeholders within R&D including Global Regulatory Affairs, Clinical Development, Medical Writing, Biostatistics, Project Management, Product Development and Intellectual Property.Â
Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into.
Role reports into the Director, Office of the CMO, and is supervised on a day-to-day basis by the Data Transparency Lead
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position (please limit the number of responsibilities to the primary ten.)
1.      As outlined in procedural documents, participate in Transparency Strategy meetings and prepare 536/2014 redacted documents for Clinical Trial Applications (CTA) submissions required to comply with the new 536/2014 Clinical Trial Regulation (CTR). Undertake these transparency activities in a timely fashion against timelines. Â
Includes
•   Transparency support for CTA packages submitted under the 536/2014 CTR during the preparation of the CTA package, the subsequent validation period, the Request for Information process (RFI), and the assessment of the CTA package leading to on time study start
•   Ongoing transparency support for studies being conducted in EU under the 536/2014 CTR (substantial modifications, additional sites, ad-hoc and other notifications)
2.      Participate in lessons learned activities and provide feedback on the new 536/2014 SOP and work instructions and provide input to required process updates
3.      Prepare redacted documents as directed for clinical studies conducted in EU that will have to transition from the Clinical Trial Directive (CTD) to the CTR
4.      Assist establishment of new way of working with redaction and anonymization vendor. Collaborate with Biostatistics, Programming and other key stakeholders to assist with scheduling and tracking deliverables, development of processes, templates and business rules for assets across all therapeutic areas
5.      As directed prepare outstanding proposed redaction packages to comply with EMA Policy 0070: policy and procedural documents (in preparation for Policy 70 to recommence)
6.      Provides expertise to project teams in global clinical transparency regulations, policy, processes and systems, including document anonymization requirements and identification of Commercially Confidential Information (CCI).
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
Education
Bachelor’s degree in a scientific/medical/pharmaceutical discipline is required.  Other commensurate qualifications and/or related experience in industry considered if equivalent.
Experience
At least 3 years working in a Clinical Development and/or regulatory affairs environment is required. Â
Sound understanding of the drug development process.
Working experience with global clinical transparency regulations, eg EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation 536/2014.
Knowledge of ICH GCPÂ
Awareness of the Clinical Trial Application process and/or the contents of the clinical modules of the Marketing Authorisation Application
Awareness of privacy regulations, eg GDPR, anonymization concepts and their application to documents (and data sets strongly preferred)
Familiar with the concept of commercially confidential information generated during the drug development pathway preferred
Working independently on assignments of moderate complexity and the ability to organize work and handle multiple projects at the same time
Demonstrated interpersonal, communication and negotiation skills to effectively work with teams and vendors in a global environment
Ability to apply knowledge and experience to solve problems in a pragmatic way
Familiar with the MS Office suite of products
Competencies
   Personal and interpersonal
•   Is thorough and accurate when accomplishing a task
•   Is customer focused
•   Is easy to approach and to talk to
•   Demonstrates appropriate values and ethicsÂ
•   Takes responsibility for own behavior
•   Relates well to all kinds of people
•   Is an attentive and active listener
•   Is seen as a (global) team player and is cooperative
Global
•   Can develop cross cultural agility.  Open to the need for flexibility and can engage with locals to get things done.
Organizational
•   Is able to write clearly and succinctly in a variety of communication settings and styles
Strategy
•   Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
•   Can learn new skills and knowledge
Energy and drive
•   Is action oriented and enjoys working hard
•   Pursues everything with energy, drive and the need to finish
Operations
•   Can orchestrate multiple activities at once to accomplish a goal, arranges information and files in a useful manner
•   Able to clearly identify the most important priorities and focus energies accordingly
•   Is a consistent communicator, providing timely information allowing accurate decisions
•   Can critically analyze and interpret complex scientific content
*Depending on experience
Position Purpose:
The Manager, Clinical Trial Disclosure and Transparency is responsible for executing disclosure and transparency activities as directed, including the redaction and anonymization of clinical trial documents required for public disclosure in compliance with regulatory requirements and policy and processes. This role will partner with internal stakeholders and external vendors for the planning, initiation and delivery of redacted/anonymized documents required for EU Clinical Trial Applications according to the EU Clinical Trial Regulation 536/2014 and Health Authority transparency submissions (eg EMA Policy 0070, Health Canada PRCI).
The incumbent will also contribute to the development and maintenance of procedures and standards that will support current and future global clinical trial disclosure requirements.Â
This role operates within a global matrix organization and is responsible for active collaboration with teams and stakeholders within R&D including Global Regulatory Affairs, Clinical Development, Medical Writing, Biostatistics, Project Management, Product Development and Intellectual Property.Â
Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into.
Role reports into the Director, Office of the CMO, and is supervised on a day-to-day basis by the Data Transparency Lead
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position (please limit the number of responsibilities to the primary ten.)
1.      As outlined in procedural documents, participate in Transparency Strategy meetings and prepare 536/2014 redacted documents for Clinical Trial Applications (CTA) submissions required to comply with the new 536/2014 Clinical Trial Regulation (CTR). Undertake these transparency activities in a timely fashion against timelines. Â
Includes
•   Transparency support for CTA packages submitted under the 536/2014 CTR during the preparation of the CTA package, the subsequent validation period, the Request for Information process (RFI), and the assessment of the CTA package leading to on time study start
•   Ongoing transparency support for studies being conducted in EU under the 536/2014 CTR (substantial modifications, additional sites, ad-hoc and other notifications)
2.      Participate in lessons learned activities and provide feedback on the new 536/2014 SOP and work instructions and provide input to required process updates
3.      Prepare redacted documents as directed for clinical studies conducted in EU that will have to transition from the Clinical Trial Directive (CTD) to the CTR
4.      Assist establishment of new way of working with redaction and anonymization vendor. Collaborate with Biostatistics, Programming and other key stakeholders to assist with scheduling and tracking deliverables, development of processes, templates and business rules for assets across all therapeutic areas
5.      As directed prepare outstanding proposed redaction packages to comply with EMA Policy 0070: policy and procedural documents (in preparation for Policy 70 to recommence)
6.      Provides expertise to project teams in global clinical transparency regulations, policy, processes and systems, including document anonymization requirements and identification of Commercially Confidential Information (CCI).
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
Education
Bachelor’s degree in a scientific/medical/pharmaceutical discipline is required.  Other commensurate qualifications and/or related experience in industry considered if equivalent.
Experience
At least 3 years working in a Clinical Development and/or regulatory affairs environment is required. Â
Sound understanding of the drug development process.
Working experience with global clinical transparency regulations, eg EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation 536/2014.
Knowledge of ICH GCPÂ
Awareness of the Clinical Trial Application process and/or the contents of the clinical modules of the Marketing Authorisation Application
Awareness of privacy regulations, eg GDPR, anonymization concepts and their application to documents (and data sets strongly preferred)
Familiar with the concept of commercially confidential information generated during the drug development pathway preferred
Working independently on assignments of moderate complexity and the ability to organize work and handle multiple projects at the same time
Demonstrated interpersonal, communication and negotiation skills to effectively work with teams and vendors in a global environment
Ability to apply knowledge and experience to solve problems in a pragmatic way
Familiar with the MS Office suite of products
Competencies
   Personal and interpersonal
•   Is thorough and accurate when accomplishing a task
•   Is customer focused
•   Is easy to approach and to talk to
•   Demonstrates appropriate values and ethicsÂ
•   Takes responsibility for own behavior
•   Relates well to all kinds of people
•   Is an attentive and active listener
•   Is seen as a (global) team player and is cooperative
Global
•   Can develop cross cultural agility.  Open to the need for flexibility and can engage with locals to get things done.
Organizational
•   Is able to write clearly and succinctly in a variety of communication settings and styles
Strategy
•   Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
•   Can learn new skills and knowledge
Energy and drive
•   Is action oriented and enjoys working hard
•   Pursues everything with energy, drive and the need to finish
Operations
•   Can orchestrate multiple activities at once to accomplish a goal, arranges information and files in a useful manner
•   Able to clearly identify the most important priorities and focus energies accordingly
•   Is a consistent communicator, providing timely information allowing accurate decisions
•   Can critically analyze and interpret complex scientific content
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Discover exciting job opportunities in the vibrant area around King Of Prussia, Pennsylvania! Home to the iconic King of Prussia Mall, the largest shopping mall on the East Coast, this region offers much more than just great shopping. With its close proximity to Philadelphia, the City of Brotherly Love, and convenient access to major highways, King Of Prussia provides a perfect blend of suburban charm and urban convenience. Explore career options in this dynamic region, known for its rich history, diverse dining scene featuring local favorites like Philly cheesesteaks, and cultural attractions such as the Valley Forge National Historical Park. Join a bustling community that boasts top-notch art galleries, performance venues like the Kimmel Center, and sports teams like the Philadelphia Eagles. Take the next step in your career and embrace the endless possibilities that King Of Prussia, Pennsylvania, has to offer!
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