Duties include those of a project manager on several clinical studies in personalized medicine:

-        Development of study project plans with principal investigator(s) and study team, including study milestones and timelines.  Provide input on operational feasibility in study design

-        Conduct study initiation with study team and monitor project progress identify potential risks or issues that may compromise projects

-        Develop detailed budgets, task lists, and resource allocation plans based on project requirements and input from study team members

-        Organize and lead on-going small project group meetings for study coordination and progress

-        Participate in negotiation and execution of relevant contracts and agreements with study sponsors, as necessary

-        Develop, manage, and maintain healthy relationships with functional groups (regulatory, clinical operations, finance and contracts and research investigators) and outsourcing partners, CROs and vendors as appropriate

-        Contribute to the development and refinement of project management tools and standard processes and provide training of best practices to project teams as appropriate

-        Ensure studies follow appropriate CGSU and institutional SOPs and GCP guidelines

• Maintaining up-to-date SFA system for upgrades, new and departing reps, new products, PDA’s, etc
• Conducting testing in a validated environment
• Training all reps on the SFA system
• Performing second tier Field Helpdesk functions as needed

• BS in related field coupled with ~2 years of similarly challenging experience
• Experience with SQL Server 2005
• Experience working with PDAs including associated testing
• Knowledge of stored procedures, Windows Mobile O/​S a plus

Successful candidate will be responsible for the following
 

• Provide Qualification/Validation Protocol, and report oversight.
• Ensure development and adherence to the project's Validation plans.
• Ensure efficient and timely qualification support in investment projects according to the regulatory and company requirements.
• Ensure adherence to company Integrated Commissioning and Qualification standards and company qualify manual.
• Very good communication skills, in both verbal and written form.
• General knowledge in various disciiplines (automation, electrical, HVAC, QC, manufacturing).

Successful candidate will be responsible for the following:

• Responsible for the planning and scheduling of production manufacturing areas.  This entails level scheduling of production lines, equipment and resources whild maintaining delivery objectives and minimizing outdates.  Maintain a thorough understanding of capacity for each product and schedules production accordingly.
• Responsible for Clinical development production planning.  Includes, creation and maintenance of bills of materials and master receipes creation and maintenance of material masters and production planning using MRP.
• Negotiate contracts and vendor agreements.  Evaluate vendor reliability; develop new supply sources, as required, in which current vendors and suppliers are inadequate.
• Develop policies and procedures for the operation of procurement activities.
• Develop and conduct organization wide training on inventory control and supply topics as needed.
• Monitor the cost, schedule and performance aspects of major subcontracts.
• Coordinate purchasing activities with other departmetns to maintain inventories at planned levels.
• Purchases materials, scientific equipment and services and office/business supplies.  Check requisitions, obtain quotes, examine bids and make awards.
• Review and approve purchases as authorized.
• May select, develop and evaluate personnel to ensure the efficient operation of the function.
• Demonstrate understanding and effective use of supply planning processes and system tools.  Create a valid supply plan which satisfies the demand plan.  Continually manage the material requirements plan to create and maintain valid material schedules in support of the master schedule.
• Work closely with procurement manufacturing and quality to ensure timely receipt release and consumption of materials.
• Monitor component inventory levels and determine when to expedite/de-expedite replenishments.
• Effectively partner with stakholder departments in identifying critical issues relative to clinical raw materials and planning.
• Liaison with Manufacturing to ensure level loading of a schedule on a daily and weekly basis that enables the organization to optimize flow and productivity while achieving production objectives.