Clinical Trial Operations Manager I
ArtechInformationSystemLLC
Posted: January 7, 2016
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Quick Summary
We are seeking a Clinical Trial Operations Manager to oversee clinical trials from start to finish, ensuring timely and efficient delivery of trials, managing a team of clinical trial coordinators, and ensuring compliance with regulatory requirements.
Required Skills
Job 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.
Manager Note: "candidates lacked the needed direct clinical supplies experience. To date we have seen several CRAs (which seems to be the closest thing and can work with on a good day), some pharmacists (not applicable at all), and some general experience non focused resumes. I understand that Clinical Supplies is niche and I understand that any person coming in will have to be trained, but there has to be some foundation. "
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.
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:Education
Bachelors Degree (Science) required
A degree in Pharmacy (Pharm.D) or Master degree prefered.
3 - 5 years of hospital pharmacy or equivalent pharm
Neha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3437 | Fax: 973.998.2599
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