Senior Manager, Clinical Disclosure office
Senior Manager, Clinical Disclosure Office
Contract
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting / financial flexibility by offering contingent labor as a variable cost.
Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.
Responsibilities :
- Utilizing CSRs, prepare results from a number of therapeutic areas, in the Client Clinical Trial Results format, for submission to the EMA's results website, EudraCT.
- Circulate the prepared results for review by key clinical team members, addressing team questions, archiving the approvals and prepared result into the document repository.
- Prepare and make the submission in EudraCT.
- Assist the clinical disclosure team with any other support required for meeting the EU backlog of results submission to EudraCT or in facilitating clinical team review of redacted CSRs for voluntary data sharing.
Skills :
- Must have a minimum of 10 years clinical research and development experience, preparation of writing protocols, interpreting trial results and preparation of CSRs.
- Ability to influence and successfully work within complex cross divisional matrix across different cultures.
- Strong negotiation and conflict resolution skills; well organized, strong planning, tracking, problem solving and decision making skills.
- Minimum Bachelor degree in a scientific discipline required (chemistry, pharmacy, biology, etc.).
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