Provides oversight for the development and implementation of innovative solutions to highly complex cross-functional operational issues requiring extensive collaboration and cooperation across functions and/or with other business units to address. Accountable for assigned, highly complex initiatives aimed at supporting and ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Identifies process improvement opportunities and mentors team members. Interprets data on complex issues, leads cross-functional project teams and makes good business decisions with minimal support.Essential Functions and Other Job Information:
- Designs, develops, communicates and implements process optimizing strategies to best support business outcomes and industry compliance requirements.
- Proactively collaborates with senior management to identify and drive continuous process optimization.
- Consults with executive sponsors and key stakeholders in support of initiatives teams to develop, optimize and improve processes, associated systems/applications, training and communications.
- Leads and/or participates in multiple large, complex process improvement initiatives and/or governance committees.
- Independently and skillfully develops process improvement processes and solutions.
- Reviews, assesses and manages updates to cross-functional/over-arching procedural documents for overall compliance with current processes.
- Acts as an Authorizing Manager for CAPAs.
- Identifies training needs, and then develops and/or approves training materials.
- Makes recommendations required to prioritize business process improvement needs.
- Responds to client or internal process audits on processes, systems, or procedures.
- Performs special projects, assignments and administrative tasks per business needs.
- Provides mentorship, guidance, support and training to staff and coaches team members in developing and implementing process improvement initiatives.
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.Job Knowledge:
Having broad expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Normally requires nomination and management committee review and approval at this level,Supervision Recieved:
Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.Qualifications:Qualifications:
Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
- Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
- Solid leadership and project management skills
- Excellent judgment, decision making, escalation and risk management skills
- Advanced process improvement skills
- Exceptional investigative and analytical skills
- Excellent interpersonal and negotiation skills
- In-depth understanding of clinical management technology and systems, and excellent computer skills
- Thorough understanding of the practices, processes, and requirements of clinical trials
- Broad understanding of procedural documents
- Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
- Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
- Capable of thinking strategically and cross-functionally
- Excellent attention to detail
- In-depth understanding of regulatory guidelines and directives
- Excellent creative and critical thinking skills