Clinical Project Manager, Clinical Operations

BioPharmX Corporation Menlo Park, CA
Reports to: Director, Clinical Operations

Position Summary

The CPM is responsible for the successful development and management of clinical studies/projects. The CPM is an expert in communicating and collaborating with CROs, data management, finance, vendors, Investigators, and internal team members for trial processes to ensure protocol timelines are met or exceeded. The CPM must be able to function independently and identify and solve critical project issues across the complete spectrum of trial execution.

Responsibilities

Tasks include, but are not limited to:

* Lead interdisciplinary, cross-functional project/study team(s).

* Understand and manage study budgets.

* Create timelines, milestones, and KPIs for tracking progress to achieve on-time and on-budget performance.

* Develop study plans and procedures.

* Serve as primary project contact with CRO(s) and vendors to ensure communication is maintained and continuously improved and reporting schedules are adhered to.

* Report on team performance against contract, expectations, and project baselines to director.

* Lead problem solving and issue resolution, develop proactive efforts to include management of risk, contingencies and issues.

* Identify quality issues within the study through regular review of site(s) communications, monitoring visit reports, data and quality assurance audit findings to implement appropriate corrective action plans; escalate findings and action plans to appropriate parties.

* Prepare and present regular project updates and serve as facilitator for all communications to project/study team(s).

* Collaborate with cross-functional groups to support milestone achievement and to manage study issues and obstacles.

* Ensure high performance and efficiency of the project/study team(s) through the scheduling of co-monitoring/accompanied site visits.

* Assist manager with change orders and budget revision.

* Assist manager with status reports, communications and resource planning.

Qualifications

* Bachelor's degree

* Knowledge of drug/ device development process and applicable standards, regulations and ICH-GCP for clinical study conduct

* Minimum of 5 years relevant clinical research experience in a drug/device company/CRO managing global projects

Knowledge & Skill Requirements

* Demonstrated ability to handle multiple competing priorities and ability to deliver results per protocol timeline

* Broad knowledge of drug/device development processes and sponsor needs – from IND to NDA

* Strong organizational, analytical and problem-solving capabilities

* Outstanding verbal and written communication and interpersonal skills

* Dynamic presentation skills including command of English language

* Ability to work under pressure within tight timelines

* Strong computer skills (MS Office and project planning software)

* Ability to travel as required (~25%) to manage CRO, site, and vendor performance

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EmailCover letter (optional)To whom it may concern,I am very interested in the Clinical Project Manager, Clinical Operations position at . I believe my skills and work experience make me an ideal candidate for this role. I look forward to speaking with you soon about this position. Thank you for your consideration.Best regards,

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