Clinical Trial & Transparency Manager Job Listing at Kelly Services in King Of Prussia, PA (Job ID US3561885_BH9811782)

Description

Every day, Kelly Engineering connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

Title: Clinical Trial Disclosure & Transparency Manager
Location: Remote / Must be located in Eastern Time Zone
Duration: 12 months +


Overview

• The Manager, Clinical Trial Disclosure and Transparency is responsible for executing CSL disclosure and transparency activities as directed, including clinical trials registration and summary results disclosure, in all regions across the global CSL organization according to CSL policy. He/she will manage the trial disclosure system in collaboration with the Senior Manager, Clinical Trial Disclosure and Transparency
• 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.
• This role, within the Office of the CMO, operates within a global matrix organization and is responsible for active collaboration with stakeholders within R&D and potentially the wider business, including Clinical Development and Medical Writing, Commercial, Medical Affairs, Legal and Communications to provide aligned transparency and disclosure deliverables and procedures.

Responsibilities
Responsible for executing CSL clinical disclosure and transparency activities in compliance with applicable global regulations and in accordance with CSL policy and SOPs, including:

• Works cross-functionally to identify clinical trials which require registration and posting of results.
• Communicates disclosure timelines to project teams, Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians.
• Prepares and executes protocol registration and summary results posting to public registries in a timely fashion.
• Manages clinical trial disclosure system.
• Assists global project teams and functions with questions regarding public results disclosure.
• In collaboration with the Clinical Trial Disclosure and Transparency Senior Manager, assists Clinical Development Teams to develop and approve layperson summaries to patients and regulatory agencies as required
• As guided, shares clinical results via the CSL corporate website as required
• Contributes to the development of high-quality clinical disclosure and transparency deliverables, processes and standards
• Provides input to regulatory compliant clinical trial disclosure and transparency processes and standards in accordance with CSL quality framework
• Works with local country affiliates to ensure consistency of information disclosed in various clinical trial registries
• Ensures consistency of information posted with publicly disclosed information such as medical publications
• Collects identified metrics on a regular basis and generates reports over time.
• Provides expertise in clinical disclosure internally
• Known as an SME on registration and public disclosure of clinical trials
• Develops further understanding on new clinical trial transparency requirements (EU CTR 536/2014, FDAAA801, etc.) and global regulatory agency disclosure and transparency requirements (FDA, EMA, PMDA, etc.)
• Responsible for developing and maintaining collaborative relationships internally and with vendors to ensure effective and efficient working relationships and the delivery of high quality outputs that support a successful portfolio pipeline
• Maintain strong working relationships with Medical Writing to ensure quality and on time registration and disclosure deliverables
• Work with vendors as required to produce high quality deliverables.

Required Qualifications

• Bachelor's degree in a scientific/medical/pharmaceutical discipline is required. Other commensurate qualifications and/or related experience in industry considered if equivalent.
• At least 3 years working in a Clinical Development and/or regulatory affairs environment is required.
• Sound understanding of the clinical development process, in particular clinical trial disclosure obligations.
• Working experience with international registration and results posting on clinical trial registries
• Demonstrated experience in clinical trial disclosure and transparency processes and systems.
• Understanding of international regulatory guidelines pertaining to clinical trial disclosure and transparency
• Knowledge of ICH-GCP, awareness of clinical publication practices and standards (i.e. ICMJE)

Additional Information

• 1st shift / Remote / Standard EST Business Hours

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone (taryn.carbone@kellyengineering.com) for immediate consideration.
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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