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

Job Complexity: Works on problems of diverse scope with subject matter input, appropriate management of data, requires good problem solving skills

Job Knowledge: Experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

Supervision Received: Normally receives detailed instructions on all work.

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 collaborators 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 0 to 2 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 to support communication in English

• Strong prioritization and time-management skills

• Knowledge of the clinical trial process

• Knowledge and understanding of ICH GCP and other relevant regulations and guidelines

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

• Strong attention to detail

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

• Demonstrated ability to prioritize tasks for efficient workload management

• Shown flexibility and adaptability

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

• 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.

Physical Requirements:

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

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

• 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 so others will understand; ability to listen to and understand information presented through spoken words and sentences.

• Frequent cross-functional interaction to acquire related information.

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

• Performs broad selection of variable tasks as determined by demands and changing conditions with little predictability as to the occurrence.

• Ability to perform under stress.

• Ability to multitask.

• Regular and consistent attendance.