Clinical Trial Operations Manager I
The Trial Supplies Operations Manager is responsible for the implementation of appropriate Clinical Supplies strategies and processes in order to achieve clinical study objectives in assigned programs.
Responsibilities Include:
• Receives the Extended Synopsis/protocol and will provide feedback /comments to Project leaders and Clinical teams
• Obtain detail information about Clinical trials assigned including IP design, countries, blinded or open label trials, distribution strategy and other details.
• Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials.
• Monitoring patient recruitment and adjust the resupply strategy as needed.
• Work in collaboration with internal and external stakeholders to plan the labeling requirements, packaging plan and domestic and international distribution.
• Initiates label request for clinical supplies meeting regulatory requirements for each market.
• Monitor the distribution plan including the IVR activities, making sure that IP are delivered in good condition for patients al all the time.
• Responsible for the Pre-Audit preparation for assigned trials, making sure that all documentation is correct and available for internal and external auditors.
• Interaction with local country representatives (IPM) and depots to coordinate over-labeling and/or rework operations.
• Constant interaction with quality (SQO), making sure that all activities related with assigned studies are within compliance.
Skills
• Strong verbal and written communication skills are required.
• Demonstrated ability to work effectively in a global matrix team environment
• Able to manage multiple projects and interact with different functional groups
• Work under pressure and tight timeliness
Education
• Bachelors Degree (Science) required
• A degree in Pharmacy (Pharm.D) or Master degree prefered.
• 3 - 5 years of hospital pharmacy or equivalent pharm
Thanks & Regards,
Akriti Gupta
Associate Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3409 | Fax: 973.998.2599
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