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Manager Clinical Project Training

Location: Northeast

Develop and revise Standard Operating Procedures (SOP’s) for global clinical operations in coordination with Project Development Process and ISO standards to consistently achieve best clinical practices in all clinical projects. Develop corporate training program encompassing all aspects of clinical project management to attain consistent implementation of global clinical programs that meet quality systems and timeline requirements.

Responsibilities:

Design training program detailing all aspects of clinical research project implementation.

Develop and implement training program for all levels of clinical project personnel.

Develop metrics for assessing quality and timelines for project implementation.

Development of skills assessment tools for project implementation team.

Ongoing assessment and revision of established clinical project development process.

Development of plan for clinical SOP requirements that integrate with quality systems plan.

Establishment of new clinical SOP’s in conjunction with Quality Assurance, ISO coordination team and Clinical Affairs Committee.

Development and implement corporate training program for SOPs.

Assist clinical teams in development of project-specific processes that reflect Standard Operating Procedure requirements.

Experience and Education:

5 years clinical research project implementation with understanding of project management, data collection, regulatory and quality assurance procedures.

Experience in SOP development and quality assurance implementation.

Demonstrated clinical research training experience.

Demonstrated knowledge of all aspects of clinical project implementation including protocol design and development, regulatory requirements, CRF and data requirements, site selection, project initiation and product handling.

Demonstrated understanding of project planning timeline development.

Experience in pharmaceutical, biotech and/or device research.

Knowledge of FDA and GCP guidelines.

Excellent written and oral communication skills.

Demonstrated computer application skills in word processing and project management programs.

Minimum BS with advanced degree preferred.