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Manager, SSU & Regulatory - Raleigh, NC
Location US, Raleigh 4800, NC
Job ID 12635
Country SSU - 3300
Regular/Temporary Regular
Full-Time/Part-Time Full-Time
Education Required Bachelors Degree
Experience Required 5 years
Travel Percentage 0 - 25%



INC Research employees don’t accept ordinary. From therapeutic experts to administrative support staff, each member of our 5,000-strong team continually searches for better. Whether that’s better clinical development through our unique Trusted Process®, or better insights from the 100-plus countries in which we operate. It means we deliver success faster, not only for our customers and the patients we serve, but also ourselves.
At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.
As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study.  This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.  

We are looking to add a Manager, Study Start-Up & Regulatory to our Raleigh team!



As a Manager, Study Start-Up & Regulatory you will be responsible for:

- Approves courses action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.  Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.

-Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned.  Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues.  Plans and negotiates resources with line management of functional areas.

-Supports management with site start-up and financial management tasks of projects, as well as strategy development for process improvement.  Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis.

-Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings.  Develops and implements training programs for appropriate departmental teams.  

-Interacts with the executive management and Legal Department and assists with the accurate creation and implementation of site start-up and regulatory management workflows.  Identifies and reports on areas of process and risk.



We are seeking candidates with the following key attributes:

-Bachelor’s degree (B.A. /B.S.) Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred
-A minimum of five (5) years of years of contracts, clinical research, or related experience that includes four (4) years of managing clinical research projects across functional areas.
- Experience managing a staff preferred.  
- Moderate experience in a clinical research organization and related contract management or site start-up experience.
-Strong Microsoft Office skills
--Superior analytical, negotiation, and organizational skills required.
- Effective oral and written communication skills are required

should you be interested in applying for this position, please visit our website: http://www.incresearch.com/careers/ and search via requisition number 12635

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

INC Research is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. We are a drug-free workplace. In the United States, INC Research voluntarily participates in the federal E-Verify work authorization program.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to jobs@incresearch.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.

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