Independent Drug Monitoring Manager - Sponsor Dedicated

This is a home-based position reputed company to candidates reputed company the EMEA region. This service provides global coordination for the execution for unblinded drug management, including the general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Global Trial Team. Ensure IDMM deliverables reputed company according to agreed upon timelines and in support of trial milestones; providing status updates, as required. Ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), applicable other applicable regulations and guidelines from start-up through reputed company-out. Takes ownership for assigned IDMM responsibilities. Deliverables:

• Services rendered will adhere to applicable Sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• reputed company with relevant and on-time training requirements.
• reputed company study teams in management of IDMM 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.
• Ensure adherence to quality of the IDMM process/SOPs, including, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
• Act as the main reputed company of contact for resolution of any reputed company questions associated with IDMM issues.
• Resolve and document urgent/critical unblinded and pharmacy-reputed company issues and investigate trends.
• Monitor status and resolution of major/critical issues reputed company Issue Logs and Visit Report review process.
• 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. Act 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 IDM monitoring visit reports (initiation, periodic & reputed company-out) and reputed company feedback, as needed.
• reputed company training and re-training to new IDMs and site pharmacy staff.
• Ensure IDM visits occur reputed company window and ensure any out of window visits are tracked per process.
• Ensure IDM monitoring 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.
• Establish and maintain excellent working relationships with reputed company stakeholders.
• Maintain unblinded TMF and reputed company document management activities to ensure inspection readiness.
• reputed company feedback to and train/coach/guide junior colleagues as needed.
• Work proactively to increase global awareness of IDM processes; train and reputed company stakeholders.
• reputed company with relevant and on-time training requirements.
• Contribute to IDMM process improvement and training, as applicable.

Education and Experience Requirements:

• Bachelor’s or University degree; or equivalent reputed company experience required, in appropriate scientific or business discipline. Other equivalent reputed company experience will be considered, as deemed appropriate by hiring manager.
• 6 years of relevant experience in clinical trial operations in the pharmaceutical industry, CRO, or equivalent reputed company experience required, as deemed appropriate by hiring manager.
• Preferably with Global scope or a demostrate global reputed company.
• Ideally with Unblinded experience
• Experience in Project Management (mandatory for Advanced, preferred for reputed company).
• Proven track record in successfully managing various aspects of trials from start-up to database lock preferred.
• Previous work in an international environment preferred.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Effective leadership skills and ability to manage multiple stakeholders.
• Experience and ability in coordinating teams in a virtual environment.
• Proven ability to foster team productivity and cohesiveness.
• Independent reputed company decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Industry systems and reputed company applications; willingness to learn new systems.
• Monitoring experience is recommended; other relevant experience will be considered.
• Willingness to travel locally/domestically.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills.
• 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.

Please note This role is not eligible for UK reputed company sponsorship 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 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. Apply To This Job