Associate Director - Clinical Operations

  • 20411 Seneca Meadows Pkwy, Germantown, MD 20876, USA
  • Full-time

Company Description

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. It operates a network of over 2,000 offices and laboratories around the world.

Job Description

SUMMARY

 The Associate Director Clinical Operations US (Associate Director CO US) is an experienced clinical research professional with strong expertise in clinical research. He/she provides leadership to different groups within the Clinical Operations department in the US and performs line management of the US Clinical Operations’ staff including administrative, budgetary, resource and performance management. The Associate Director CO US develops and implements strategic planning and departmental objectives to align with the corporate goals to advance the company’s mission and objectives and to promote revenue, profitability and growth as an organization.

REPORTING LINE

Directly reports to the Director Global Clinical Operations

SCOPE

·       Business Structure Managed: US Clinical Operations (within Life Sciences – Clinical Research)

·       Size of Employee Base: 20

·       Geographic coverage: United States

·       Regulatory Environment: complex

·       Customer Base: complex multi-industry across all geographies

JOB FUNCTIONS

·       Lead team of 18 Project Managers, Lead CRAs, CRAs and Clinical Trial Assistants

·       Oversee US operations with responsibility for overall quality and timeliness of deliverables

·       Develop and execute strategies for generating business leads

·       Evaluate and implement process improvements aimed at improving quality and efficiency

·       Manage US team to achieve efficiency and cost-effective allocation of resources

·       Organize and facilitate client governance meetings to ensure ongoing evaluation of and improvements to SGS clients’ customer experience

·       Prepare operational reports and financial forecasts for senior management

SUPERVISORY RESPONSIBILITIES

Supervises others: Yes

Has hiring and terminating responsibilities: Yes

Number of employees directly reporting to this job: 4 Supervisory Employees, 20 Non-Supervisory Employees

 

Qualifications

EDUCATION AND EXPERIENCE

Required:

·       Bachelor’s degree in relevant scientific field AND

·       Minimum 12 years of direct clinical research experience in a CRO, pharmaceutical or biotechnology environment.

·       Previous supervisory or team leadership experience in a multi-disciplinary environment.

·       Thorough knowledge of drug development process and GCP is required.

·       A minimum of 5 years of prior Project Management experience in clinical research.

Preferred:

·       Masters in a relevant scientific field.

KNOWLEDGE / SKILLS / ABILITIES

Language Skills: English - Advanced

Mathematical Skills: Intermediate

Reasoning Skills/Abilities: Advanced

Computer Skills: Proficient in MS Office and MS Project

 TRAVEL

Travels up to 15% of time. Some travel might be international.

 EQUIPMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers and phones.

PHYSICAL DEMANDS OF THE JOB

Physical/Sensory Demands Frequency Requirements:

•         Stand - Occasionally

•         Move or traverse - Occasionally

•         Sit - Frequently

•         Use hands -

•         Reach with hands and arms - None

•         Climb or balance - None

•         Stoop, kneel, crouch or crawl - None

•         Talk/hear - None

•         Taste/Smell - None

•         Lift/carry/push or pull - None

Vision Requirement:

•         No special vision requirements

Auditory Requirements:

•         No special auditory requirements

SAFETY CATEGORY

•         Low-Exposure: Has an indirect role and no access to operations where failure could result in serious harm to public or employee well-being, Group assets or the environment.

 WORK CONDITIONS / EXPOSURE TO ENVIRONMENTAL CONDITIONS

Location of the Job: Germantown, MD / USA

 Work Schedule:

For Non-Exempt roles:

•         Work schedule is outlined in the offer letter

•         Job requires working flexible schedule

 For Exempt roles:

•         Business hours are Monday through Friday, 8:00 a.m. to 5:00 p.m.

•         Work requires willingness to work a flexible schedule

•         Longer hours, evenings and/or weekend work will be necessary occasionally/frequently as job duties demand

 Environmental Conditions Requirements:

•         Wet or humid (non-weather) conditions - None

•         Work near moving mechanical pats - None

•         Work in high, precarious places - None

•         Fumes or airborne particles - None

•         Toxic or caustic chemicals - None

•         Outdoor weather conditions - None

•         Extreme cold (non-weather) - None

•         Extreme heat (non-weather) - None

•         Risk of electrical shock - None

•         Work with explosives - None

•         Risk of radiation - None

•         Vibration - None

•         Bio-hazard - None

Noise level:

•         Very quiet (examples: isolation booth for the hearing test)

•         Quiet

Other Physical/Work Environmental Exposures:

•         None

 

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

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