Clinical Trial Operations Manager I
artechBridgewater, NJ
Clinical Trial Operations Manager I
artechBridgewater, NJManager L7
Pharmaceutical Preparation ManufacturingDrugs and Druggists' Sundries Merchant WholesalersResearch and Development in the Physical, Engineering, and Life Sciences
APPLY NOW (opens in a new tab)Company Description:
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.
Job Description:
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.
- SkillsStrong 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
Qualifications:
EducationBachelors Degree (Science) required A degree in Pharmacy (Pharm. D) or Master degree prefered.3 - 5 years of hospital pharmacy or equivalent pharm
Additional Information:
- Thanks & Regards, Akriti Gupta
- Associate Recruiter
- Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3409 | Fax: 973.998.2599 Connect with us on - LinkedIn | Facebook | Twitter
Summary
Type: Contract
Function: Management
Experience level: Mid-Senior Level
Industry: Pharmaceuticals
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Level
Manager L7
Location
Bridgewater, NJ
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Industry
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Posted
41 days ago