Project Manager

Project Manager

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Overview- Responsible for the success of the global drug development, manufacturing, clinical trials; coordinates the operational aspects of ongoing global clinical trials to ensure meeting all required timelines as well as adherence to budget, quality and performance expectations.

Responsibilities-

• Manage global clinical trial(s) from study start-up to close-out.
• Ensure study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local Regulations.
• Manage study budget, timelines and insourcing/outsourcing partners to the required standards.
• Contribute to study concept, protocol, clinical study report as well as other critical study documents as required.
• Vendor Management, inclusive of selection, negotiation, implementation and management of vendor's Statements of Work/Scope of Work (SOW).
• Serve as the primary study contact during trial conduct including, but not limited to, regular conferences calls and team meetings with appropriate functional areas, management and vendors as necessary.
• Plan, manage and report on global clinical trial(s) through oversight of cross-functional study activities.
• Identify, resolve or escalate issues involving study timelines and deliverables.
• Coordinate and manage resources assigned to the study.
• Ensure that the study is adequately staffed throughout the lifecycle of the trial.
• Collect, track and report established Key Performance Indicators (KPIs) such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc.
• Ensure adequate protocol related and process training of all study team members.
• Provide effective management on all protocol deviations/violations to ensure proper documentation and proactively work with Investigative sites to reduce their occurrence.
• Manage the preparation for interim and primary analysis reports as applicable.
• Prepare and provide oversight/coordination of Investigator Meetings.
• Provide regular study updates to project team leads globally, if applicable.
• Provide first tier support for protocol, SOP and system questions.
• Proactively escalate performance related concerns with appropriate line management.
• Develop and manage team member's transition plan when required.
• Provide management with routine updates as established regarding the status of the clinical trial.
• Evaluate current processes for efficiencies and quality as well as make recommendations to management for improvements.
• Other duties as defined by management.

Qualifications

Knowledge, Skills, and Abilities-

• Good working knowledge of ICH, GCP and FDA guidelines/regulations.
• Good managerial, organizational and negotiation skills.
• Good verbal and written communication skills.
• Solid understanding of the drug development process with a special emphasis on clinical development.
• Ability to multi-task
• Excellent computer skills
• Strong interpersonal skills
• Passion for customer service

Qualifications-

Education and Work Experience-

• Four year degree in appropriate field from an accredited institution
• Minimum five (5) years' experience in life sciences or medically related field, including clinical research
• Study planning and set-up, maintenance, and close-out experience
• Vendor management and Vendor Communications experience
• Previous trial management experience preferred
• Project Management – Budget, Process, Risk/issue, etc. management experience
• Data Analysis
• Experience with SOP's and Technical Writing
• Supplier Management