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.
BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Seven or more years of relevant clinical trials experience, with at least four years of experience as a travelling CRA in the pharmaceutical industry
1+ years of trial management experience
Experience in CNS required
Travel required up to 20-25% of the time
Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
Demonstrated ability to work independently and in a team environment
Develop an understanding of the clinical supply chain organization and its processes.
Interacts with global external vendors and cross functional support teams.
Responsible for completing specific tasks for assigned projects and studies.
May work on projects with peers from other departments or functions.
Ability to deliver under minimal supervision of projects with varying complexity.
Collation and archive approvals from different stakeholders and update the label text library database accordingly.
Executes to a pre-established timeline and project plan and is responsible for completion of specific milestones.
Mitigate issues and concerns to the label requestor.
Reviews GMP documentation for operational and technical accuracy.
Works with team members and supervisor to identify and resolve problems.
Develops internal cross-functional and external relationships. Manages issues and fosters teamwork.
Participates on cross-functional teams as necessary.
The Clinical Trials Manager is responsible for the day-to-day activities associated with managing clinical studies.
Working closely with the Associate Director, Clinical Operations and collaborating with colleagues in other functions, the Clinical Trials Manager supports the operational team to ensure excellent operational oversight of clinical studies.
The Clinical Trials Manager contributes to and manages the project plans, manages and oversight of vendors, performs tasks during protocol design to final CSR, to produce high-quality study data, adherence to Good Clinical Practice and to achieve corporate goals on time and on budget.
Roles and Responsibilities:
Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB.
Organize and participate in investigational meetings and site training.
Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foste
August 10, 2017 – Clinical Trials, Compliance & Safety – p b Job Description: /b /p p b Must Have Skills (Top 3 technical skills only) * /b /p ul li Strong understanding of Interactive Voice
April 26, 2017 – Clinical Trials Management Associate – II – p b Essential Duties and Job Functions: /b /p ul li With limited supervision conducts site evaluations/initiations and closeout visits in
April 26, 2017 – Clinical Trials Manager – I – p b Responsibilities: /b /p ul li Must meet all requirements for Senior Clinical Research Associate position and have demonstrated proficiency