Clinical Research Director
Company Description SGS is the world's leading inspection, verification, testing and certification company.
SGS is recognised as the global benchmark for quality and integrity.
With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
Job Description SUMMARY The Director Clinical Research US is an experienced clinical research professional with strong expertise in clinical research.
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 US Clinical Operations team is an affiliate of a larger Clinical Research team based in Europe with over 500 employees and we are looking to further expand our service offering and operational team in the US The Director Clinical Research 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 LINEDirectly reports to the Director Global Clinical OperationsSCOPE Business Structure Managed:
US Clinical Operations (within Life Sciences - Clinical Research) Size of Employee Base:
8 Geographic coverage:
United States Regulatory Environment:
complex Customer Base:
complex multi-industry across all geographiesJOB FUNCTIONS Lead team of 8 including Project Managers, Lead CRAs, CRAs and Clinical Trial Assistants and Administrative Assistant Oversee US operations with responsibility for overall quality and timeliness of deliverables Develop and execute strategies for generating business leads- Support Business Development activities in US including presentations and bid defense meetings- Develop, execute and provide ongoing management for a program that supports a robust NAM site identification and relationship development strategy in collaboration with the global feasibility team 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 managementSUPERVISORY RESPONSIBILITIESSupervises others:
YesHas hiring and terminating
Responsibilities:
YesNumber of employees directly reporting to this job:
3 Supervisory Employees, 5 Non-Supervisory EmployeesQualifications EDUCATION AND EXPERIENCE Required:
Bachelor's degree in Science Minimum 10 years of direct clinical research experience in a CRO, pharmaceutical or biotechnology environment.
- Previous experience managing early phase (I/II) studies- Experience developing and managing site relationships 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:
Master of Science.
KNOWLEDGE / SKILLS / ABILITIESLanguage Skills:
English - AdvancedMathematical Skills:
IntermediateReasoning Skills/Abilities:
AdvancedComputer Skills:
Proficient in MS Office and MS Project TRAVEL Travels up to 15% of time.
Some travel might be international.
EQUIPMENTThis job operates in a professional office environment.
This role routinely uses standard office equipment such as computers and phones.
PHYSICAL DEMANDS OF THE JOBPhysical/Sensory Demands Frequency Requirements:
Stand - Occasionally Move or traverse - Occasionally Sit - Frequently Use hands - FrequentlySAFETY 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.
Additional Information 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, skill, and/or ability 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.
SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message.
You will be called back shortly.
Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
SGS is recognised as the global benchmark for quality and integrity.
With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
Job Description SUMMARY The Director Clinical Research US is an experienced clinical research professional with strong expertise in clinical research.
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 US Clinical Operations team is an affiliate of a larger Clinical Research team based in Europe with over 500 employees and we are looking to further expand our service offering and operational team in the US The Director Clinical Research 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 LINEDirectly reports to the Director Global Clinical OperationsSCOPE Business Structure Managed:
US Clinical Operations (within Life Sciences - Clinical Research) Size of Employee Base:
8 Geographic coverage:
United States Regulatory Environment:
complex Customer Base:
complex multi-industry across all geographiesJOB FUNCTIONS Lead team of 8 including Project Managers, Lead CRAs, CRAs and Clinical Trial Assistants and Administrative Assistant Oversee US operations with responsibility for overall quality and timeliness of deliverables Develop and execute strategies for generating business leads- Support Business Development activities in US including presentations and bid defense meetings- Develop, execute and provide ongoing management for a program that supports a robust NAM site identification and relationship development strategy in collaboration with the global feasibility team 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 managementSUPERVISORY RESPONSIBILITIESSupervises others:
YesHas hiring and terminating
Responsibilities:
YesNumber of employees directly reporting to this job:
3 Supervisory Employees, 5 Non-Supervisory EmployeesQualifications EDUCATION AND EXPERIENCE Required:
Bachelor's degree in Science Minimum 10 years of direct clinical research experience in a CRO, pharmaceutical or biotechnology environment.
- Previous experience managing early phase (I/II) studies- Experience developing and managing site relationships 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:
Master of Science.
KNOWLEDGE / SKILLS / ABILITIESLanguage Skills:
English - AdvancedMathematical Skills:
IntermediateReasoning Skills/Abilities:
AdvancedComputer Skills:
Proficient in MS Office and MS Project TRAVEL Travels up to 15% of time.
Some travel might be international.
EQUIPMENTThis job operates in a professional office environment.
This role routinely uses standard office equipment such as computers and phones.
PHYSICAL DEMANDS OF THE JOBPhysical/Sensory Demands Frequency Requirements:
Stand - Occasionally Move or traverse - Occasionally Sit - Frequently Use hands - FrequentlySAFETY 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.
Additional Information 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, skill, and/or ability 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.
SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message.
You will be called back shortly.
Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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