Study Director I - Pharmacokinetics
Study Director I - Pharmacokinetics
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Job Description
Imagine being involved in cutting edge projects that change the course of our industry daily. Labcorps work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. You will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.
We have an excellent career opportunity for aStudy Director IPharmacokinetics to join our growing team in Madison WI.If you have a passion for science and enjoy a fast paced collaborative environment this is an ideal position for you!
Position Summary:
The Study Director I is responsible for managing the design conduct and reporting of studies to meet scientific regulatory and client requirements. They are the single point of study control and has overall responsibility for the scientific technical and regulatory conduct of studies as well as for the interpretation documentation and reporting of results. Close and regular liaison with the client is of primary importance. They will demonstrate competence in directing standard study types. Most studies undertaken will be nonGLP studies and routine GLP studies.
Candidates given best consideration will possess the following:
Experience in a range of techniques and approaches relevant to the department and/or unique expertise for a specific scientific service
Awareness of requirements for working within a GLP GCP and GMP (as appropriate) environment
Previous data interpretation and report writing experience
Strong client relationship building and management skills
Excellent communication skills
Strong attention to detail organization and time management skills
Ability to help foster a high professional standard and encourage good staff relationships
Working knowledge of software (e.g. MS Word Excel) and general IT skills
Essential Job Duties:
Ensures that studies are performed to the required scientific regulatory and client standards in accordance with the study protocol and Covance standard operating procedures.
Applies up to date knowledge and application of current GLP GCP and regulatory guidelines relevant to study conduct.
Uses knowledge of relevant assays and general expertise in the drug development process to offer guidance and suggestions on study design to meet clients requirements and plans accordingly (timelines critical deadlines etc..
Prepares and completes study documents in partnership with study coordinators to meet client and regulatory requirements (outlines protocols reports etc.. Ensures final report is compliant with SOPs and regulatory guidelines.
Manages projects and client interactions. Provides clients with regular progress updates and ensures their expectations are met.
Effectively communicates study design project requirements and performance expectations to the study team. Maintains regular and timely communication within study team including startup ongoing and closeout meetings. Ensures that all study communication is documented and maintained.
Monitors/reviews study progress always and anticipates problems that may affect timing quality. Considers & discusses appropriate actions to resolve such problems. Issues directives and follows up to ensure compliance to requirements.
Manages study changes and ensures all additional costs are captured. Applies company procedures for financial resource and contracting requirements.
Consistently meets on time delivery targets (protocols results reports).
Monitors and reviews client satisfaction to provide feedback to team and ensure repeat business.
Education:
Bachelor of Science degree in an appropriate scientific discipline with some research experience in a relevant field required
PhD preferred
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase Plan. Casual PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information pleaseclick here.
Why People choose to work at Labcorp:
At Labcorp it is our people that make us great its what our clients our partners and most importantly what our employees say. Here you will have the opportunity to collaborate with extraordinary people with diverse viewpoints. You will discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond.We help our clients develop medicines that improve health and improve lives of their family and friends.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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Required Experience:
Director
Employment Type
Full-Time
