Kelly Services Clinical Trial Transparency Manager in Cambridge, Massachusetts
kelly Services is seeking an experienced CLinical Trial Transparency manager for a 1 year contract with our TOP client in Cambridge, MA.
Title: Clinical Trial Registration Results Workstream Lead
The Clinical Trial Registration and Results Disclosure Workstream lead WSL-CTR R will be an expert on listing clinical trial protocol and trial results on public websites ClinicalTrials.gov, EudraCT, EU PASS, Germany and company webpage .As the WSL-CTR R, he/she will oversee all work outsourced to the vendor and is responsible for ensuring compliance with legal/regulatory requirements e.g. US Final Rule and industry commitments e.g. PhRMA/EFPIA Principles .
On an ongoing basis, the WSL-CTR R will communicate with the vendor, the internal Program Leads, and the internal head of Clinical Trial Transparency CTT business operations.
The key responsibilities of the WSL-CTR R are as follows: Provide subject matter expertise on registration and results disclosure requirements, process, etc. primary contact for vendor and internal staff for daily registration and results disclosure activities and routine reporting monitor planned activities and escalate any risks review completed work and perform quality spot checks to ensure compliance establish forecast for future activities and work with vendor and internal head of CTT business operations to plan resources accordingly document lessons learned and develop key messages to reinforce positive outcomes and/or prevent issues in the future work with vendor to establish metrics to oversee activities; monitor the metrics on an ongoing basis establish agenda for ongoing workstream lead meetings, document minutes, and follow-up on all action items maintain process documentation SOP, Job Aid, Training Materials, etc. provide support for PharmaCM system guidance regarding how to, troubleshooting, incorporate system elements in SOPs, etc. develop communication materials to build awareness of protocol registration and results disclosure process, new requirements, etc. maintain decision tree regarding the requirements for all registration and results US, EU, internal policy, Germany, etc. produce status reports.
This role will perform oversight of vendor activities as all data entry is completed by vendor outsourcing team. This is not a data entry position; however, the WSL-CTR R must have hands-on experience in order to be effective in this role . As an expert in CTT, the WSL-CTR R must remain informed of the external drivers regulatory/legal requirements, trade association principles, industry benchmarking, standards development, etc. , as well as internal activities, that impact our policy and processes. He/She may be assigned one or more areas where they will lead and/or support efforts to assess new requirements, develop communication materials, implement change management, etc.
Bachelors Degree Must be knowledgeable in Clinical Trial Transparency requirements Must have hands-on experience in registering protocol and disclosing results on ClinicalTrials.gov and EudraCT.
In addition, experience with other global registries e.g. ENCePP, Germany strongly preferred.
Strong understanding of the clinical development life cycle.
5+ years in industry, working in one or more of the following functions supporting the execution of clinical trials: clinical operations, clinical development, medical writing, statistics, regulatory, safety, quality.
Experience leading global cross-functional projects.
For immediate consideration, if you meet the above requirements, please email a current copy of your CV to email@example.com or click 'apply now'.
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.
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AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people
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talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.