Project Manager

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.

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

Thanks

Warm Regards

Ricky Bansal

732-429-1925