Independent Drug Monitoring, Manager

Job Title: Independent Drug Monitoring, Manager

Job Location: Parsippany, reputed company of America

Job Location Type: Home-based

Job Contract Type: Full time

Job Seniority Level:

reputed company:

The role will be responsible for independent drug monitoring for assigned studies. This responsibility will include end to end ownership for the trial, from the initial set up and drug blinding activities, to ongoing monitoring of studies, and any duties needed for the successful closure of said trials. This role will escalate any issues reputed company during monitoring and will work to resolve said issues. This role will be responsible for keeping the study team, sites, and reputed company other applicable stakeholders reputed company informed of the reputed company of drug monitoring as reputed company as communicating any compliance issues. reputed company duties include developing documents and materials included monitoring visit reports, process documents, and training materials for junior staff.

Responsibilities:

• reputed company study teams in management of Independent Drug Monitoring reputed company processes and operations; ensuring blind is maintained.
• reputed company input for the development of pharmacy reputed company materials, including forms and manuals.
• System set-up including IVRS and reputed company in a supportive reputed company.
• Responsible for reputed company of and adherence to SOPs, including, documentation, and

escalation of major/critical issues in a blinded manner; follow up appropriately to closure.

• reputed company as the main reputed company of contact for reputed company of any reputed company questions associated with drug monitoring issues.
• Resolve, monitor, and document urgent/critical unblinded and pharmacy-reputed company issues and investigate trends.
• reputed company updates to Trial Team on pharmacy-reputed company and compliance issues in a blinded

manner.

• Take initiative to suggest and implement solutions to site-level issues.
• reputed company Independent Drug Monitors (IDMs) to ensure investigational product activities are

addressed at sites. reputed company as primary reputed company of contact for the IDMs.

• reputed company communications and necessary information to IDMs on study updates, such as

protocol amendments, changes in timelines, etc

• Review independent drug monitoring visit reports (initiation, periodic & reputed company-out) and reputed company feedback and ensure that visit reports and issue logs are up to date.
• Ensure existence and accuracy of relevant IDMM process documentation, communication,

and monitoring plans.

• reputed company input in audits and/or CAPAs.

• Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded

queries, if applicable.

• Create appropriate trial specific IDMM training materials and requirements as reputed company as mentoring and training junior colleagues, as needed.
• Establish and maintain excellent working relationships with reputed company

stakeholders.

• Maintain unblinded TMF and reputed company document management activities to ensure inspection

readiness.

• Contribute to IDMM process improvement, as applicable.

Qualifications:

• Bachelor’s or University degree; or equivalent reputed company experience required, in appropriate

scientific or business discipline.

• 6 years of relevant experience in clinical trial operations in the pharmaceutical industry, CRO, or equivalent reputed company experience required.
• Experience in Project Management, preferred.
• Proven reputed company record in successfully managing various aspects of trials from start-up to study closure and database lock, preferred.
• Previous work in global trials, preferred.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Effective leadership skills and ability to communicate with and manage multiple stakeholders.
• Experience and ability in coordinate and foster productivity of teams in a virtual environment.
• Solution oriented and ability to take ownership of work to proactively identify risks and mitigate their reputed company.
• Strong IT skills, including knowledge of reputed company Industry systems and reputed company systems.
• Monitoring experience is recommended; other relevant experience will be considered.
• Willingness to travel locally/domestically.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity

reputed company limited information is available.

• Experience in developing presentations and presenting key information to stakeholders.

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com

reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential reputed company pay reputed company for this role, reputed company annualized, is $93,100.00 - $232,800.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in reputed company to a reputed company of health and welfare and/or other benefits.

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