About The RoleRepresents the single point of control for a study and is responsible for the interpretation, analysis, documentation, and reporting of study results.
What You'll Do Here- Performs functions of a Study Director with a full SD workload, including GLP studies.
- Functions as an independent Study Director with overall responsibility for the technical conduct of assigned studies, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.
- Performs functions in accordance with GLPs and other applicable regulations and/or guidance as they apply to the conduct of nonclinical studies.
- Consults with Sponsors, contributing scientists, and other key individuals during Protocol development to optimize Protocol design and appropriately outline study objectives.
- Coordinates all phases of a non-clinical study in collaboration with internal departments, external vendors, and clients.
- Ensures that current copies of approved Protocol and Amendments are available to all study personnel and Sponsors.
- Obtains approval of the study by the IACUC using the appropriate IACUC submission forms.
- Plans and hosts client visits.
- Monitors, tracks, and communicates study milestones effectively to all contributors (internal and external), including the Sponsor.
- Assures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
- Assures that unforeseen circumstances and deviations that may affect the quality and integrity of the nonclinical laboratory study are evaluated for their potential impact on the study and communicated to the Sponsor.
- Independently interprets and integrates the study data to prepare high-quality reports with minimal assistance.
- Responds to internal and external Quality Assurance (QA) audits to maintain regulatory compliance.
- Assures that Sponsors are appropriately informed of ongoing study activities, results, and any corrective actions (as applicable).
- Confirms that all raw data, documentation, Protocol, specimens, and study reports are transferred to the archives during or at the close of the study.
What You'll Need to Succeed- BSc or equivalent degree in toxicology or related field. May have PhD with limited experience
- 6 months-5 year's experience with PhD or MSc
- 5-8 year's experience with BS
- Previous experience with reproductive toxicology, safety pharmacology, or metabolic diseases is preferred
- MS Word, Excel, Outlook and Power Point
- Verbal and written communication skills in English; the ability to read, analyze, understand, discuss, and interpret complex scientific and regulatory documents. Ability to effectively communicate scientific data interpretation and conclusions.
- Ability to multi-task and maintain organization in a fast paced, rapidly changing environment. Ability to manage change. Demonstrated expertise in scientific discipline. Strong planning and organizational skills. Ability to work effectively and cooperatively in a team environment under significant time pressure. Demonstrated attention to detail and consistent ability to operate with accuracy and quality. Proven presentation and facilitation skills. Ability to successfully operate independently with minimal guidance.
What We OfferThe salary range estimated for this position is $79,000 - $120,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes:- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
Altasciences' Incentive Programs Include:- Training & Development Programs
- Employee Referral Bonus Program
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