Manager, Clinical Process Management

Job Summary

The Manager, Clinical Process Management will be responsible for the management, development, maintenance and implementation of processes and procedures used by Clinical Management & Operations to successfully manage clinical studies being sponsored by Otsuka. The Manager, Clinical Process Management will drive day-to-day activities to ensure operational SOPs are effectively managed and maintained from a governance and on-going operations perspective.

Job Description

• Act as the primary point of contact for development, maintenance, and enhancement of departmental policies and procedures
• Facilitate implementation of key standard processes that lead to positive and measurable impact for clinical programs managed by the Clinical Management & Operations team (e.g. quality, efficiency, consistency)
• Lead the efforts and process to gather and create SOP requirements associated with process improvements
• Act as the supportive source of knowledge for all departmental SOPs, WPs and associated controlled documents
• Lead the analysis and recommendations for SOP effectiveness
• Drive the day-to-day activities to ensure the accuracy, governance, and maintenance of SOPs.
• Lead the escalation/communication of risks and issues associated with departmental processes as appropriate
• Manage all aspects of the SOP document control and approval system and processes
• Support the development process related training as requested
• Assist Subject Matter Experts (SMEs) to document processes, and draft SOPs and facilitate SME review and input for internal and external departmental SOP development and maintenance activities
• Gather end-user feedback to aid in the development and/or enhancement of SOPs
• Review, suggest, revise, consult, and re-write existing SOPs.
• Develop and define the terminology used in SOP documents so they are clearly understood by all audiences that read and/or use them.
• Support and manage coordination of activities across Clinical Management & Operations for the completion and continued execution of process improvement and compliance related initiatives
• Assuring compliance with departmental, SOP, compliance, and corporate training
• Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
• Performs other duties, as assigned.

Qualifications/ Required

Knowledge/ Experience and Skills:

• 7+ years of experience in the pharmaceutical/biotechnology industry (preferred, not required)
• Strong knowledge of regulatory and GCP/ICH regulations
• Experience and thorough understanding of essential documents involved in the management of clinical trials and use of electronic TMF platforms for archiving of essential trial documents
• Experience with contracting activities and understanding of clinical study vendors in preferred
• Experience in process development/management
• Experience working on process improvement initiatives
• Strong leadership and mentoring skills
• Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
• Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members and direct reports
• Experience managing teams including direct line management responsibilities
• Ability to work effectively within a team matrix as well as independently
• Some travel may be required

Educational Qualifications

• Bachelor's degree in a relevant discipline required with relevant experience in the clinical research industry

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $102,101.00 - Maximum $145,970.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:  

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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