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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