Senior Manager, Clinical Disclosure office

Artech Information System LLC; East Hanover (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading IT staffing company in East Hanover is seeking a Senior Manager for Clinical Disclosure. The role requires over 10 years of clinical research experience and involves preparing submissions to the EMA's EudraCT platform. Candidates must have strong negotiation skills and the ability to work within complex team structures. This position is contract-based and offers the opportunity to influence clinical trial processes while ensuring compliance with EU regulations.

Qualifications

• Minimum of 10 years clinical research and development experience.
• Strong negotiation and conflict resolution skills are essential.
• Ability to work across different cultures and teams.

Responsibilities

• Prepare results for submission to the EMA's results website, EudraCT.
• Circulate results for review by key clinical team members.
• Assist with meeting the EU backlog for results submission.

Skills

Clinical research and development experience

Influencing within a cross-divisional matrix

Negotiation and conflict resolution skills

Planning and tracking skills

Education

Minimum Bachelor's degree in a scientific discipline

Job description

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.

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.).