Associate Process, Standards & Training Director

Job Description

This role leads process creation and optimization for Development Operations functions including: Biostatics, Clinical Operations, Data Management, Programming, R&D Strategic Outsourcing, and Technical Operations. Collaborate with department management to develop or update standard operating procedures (SOP), work instructions (WI), process maps and other process-related documents and tools. Leads initiatives to develop training materials and competency measures with Department and Company policies and helps promote a learning environment within Development Operations to support staff growth and development while ensuring compliance.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Leads Development Operations process document lifecycle activities to ensure compliance with regulatory requirements and company policies, including:o Process Flow Developmento Document Developmento Document Routingo Process changes management/communication Partners with the Head of Process, Standards, and Training to manage SOP governance activities. Leads the creation and management of study toolbox content. Collaborates with GCP Quality in the review of audit and inspection reports to assess process improvements. Supports inspection readiness activities. Identifies and supports remediation issues related to process and training assigned to Development Operations functional areas. Develops and reports metrics to reflect progress and status of process and training activities.

SUPERVISORY RESPONSIBILITIES: None.

EDUCATION/EXPERIENCE/SKILLS: Education: BS/BA in biological sciences or related field and ten years of related experience; or, MS/MA in biological sciences or related field and eight years of related experience; or, PhD in biological sciences or related field and five to eight years of related experience; or, Equivalent combination of education and experience.

Experience: Typically requires 10-12 years of related experience or the equivalent combination of experience and education/training. Experience with inspection readiness. Experience with training development and implementation required. Experience with process improvement methodologies and process design.Knowledge/Skills/Abilities: Advanced understanding of ICH GCP requirements, CFR and FDA and related regulations required. Strong understanding of drug development and clinical trial execution, including other functional areas involved in clinical trials required. Experience with Standard Operating Procedure (SOP) and process development and management required. Experience with training, training content development and the rollout of processes required. Excellent verbal and, written, communication and presentation skills. Excellent organizational skills and attention to detail are essential. Ability to prioritize and multi-task successfully in a fast-paced environment and changing environment. Ability to review documentation, processes and procedures related to study activities and identify issues/problem areas, assesses compliance and communicate findings to the appropriate team(s) and management. Ability to work both independently and in a collaborative team setting. Demonstrated leadership and project management skills. Excellent interpersonal and communication skills, both written and oral, including ability to develop strong relationships with internal and external stakeholders. Demonstrated ability to think strategically across the organization. Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.