Clinical Compliance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Executes quality and compliance strategies and initiatives across the organization. Manages assigned initiatives aimed at supporting quality delivery and compliance to optimize processes, behaviors, performance, and audit readiness. Interprets data on complex issues, leads teams and makes good business decisions with support.  Provides mentoring and expertise to advance the vision of the department.

Essential Functions and Other Job Information:

Essential Functions

• Research and address issues using problem solving methodology, documents in accordance with ALCOA principals and tracks metrics related to quality and compliance activities.

• Leads quality and compliance processes and ensures appropriate execution and completion.

• Leads and/or participates in process improvement initiatives.

• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).

• Develops varied support materials, presentations, and/or tools to support department's remit and strategies.

• Provides training and guidance to junior team members.

 Job Complexity

Works on problems of diverse scope with varied subject matter input, appropriate management of data requires good problem solving and communication skills.

Job Knowledge

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Supervision Received

Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions and escalating issues.

Business Relationships

Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

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 8+ years). 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:

• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing

• Strong organizational and time-management skills

• Extensive knowledge of the clinical trial process

• Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines

• Highly developed problem-solving skills, including root cause analysis, corrective/preventive action(s) and effectiveness checks

• Effectively works independently or in a team environment

• Strong negotiation and conflict management skills

• Strong attention to detail

• Strong computer skills; ability to learn and become proficient with appropriate software

• Demonstrated ability to prioritize competing demands and manage workload

• Proven flexibility and adaptability

• Effective judgment, decision making, escalation, and risk management skills

• Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting

• Strong creative and critical thinking skills

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed from a remote home based office environment with exposure to electrical office equipment.

• Occasional travel to office locations, both domestic and international, may be required.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Ability to perform under stress.

Ability to multitask and prioritize tasks to manage workload and meet deliverables.

• Regular and consistent attendance.