Associate Principal Scientist, Clinical Research
Associate Principal Scientist, Clinical Research
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
JOB DESCRIPTION SUMMARY
The Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design coordinate monitor and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies and occasionally Good Laboratory Practice (GLP) studies.
The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study.
The Associate Principal Scientist can also be responsible for several effectiveness studies within a project participating as the clinical representative in project teams as assigned.
MAJOR ACTIVITIES AND RESPONSIBILITIES
Work Independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Inclusion.
Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives budget resources timelines and the study protocol/related documentation.
Provide overall leadership and support to the study team.
Identify and select Investigators laboratories and/or CROs.
Apply for the necessary study permits and licenses with support of local regulatory staff within the specified study timeline.
Train the study team on the Study Protocol
Ensure the timely selection and ordering of study materials.
Ensure compliance of administrative aspects of the study (budgets and agreements) with the applicable laws and our Companys policies and procedures Plan and coordinate the monitoring and data management activities of each study.
Ensure that the study is conducted according to legal requirements GCP and the applicable internal policies and procedures.
Prepare the Final Study Report
Maintain contact with all stakeholders (project leader regulatory affairs quality assurance etc.) and keeps them informed of the study progress.
May be the Global Clinical Research (GCR) representative in the project team.
Assume responsibility for certain monitoring and data management tasks (e.g. User Acceptance Test of electronic Case Report Forms)
Monitor clinical studies under the leadership of other Scientists.
Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
Conduct quality control inspections of study protocol study documentation files and reports.
Serves as a contact and liaison with other internal departments on specific projects and with external partners such as universities or regulatory authorities.
Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.
Supervise trainees and provide mentorship and support to other GCR staff.
Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
Conducts post-marketing studies.
Prepares scientific publications according to the need of the company.
QUALIFICATION PROFILE
Education:
Doctor of Veterinary Medicine OR equivalent veterinary degree
Required:
Four years in clinical research or similar research role.
Experience in a clinical study related role.
Strong scientific writing ability
Principled verbal and written communications
Proficient in MS Office applications
Understanding of GCP Good Clinical Practices guidelines.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$139600.00 - $219700.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Preferred Skills:
Job Posting End Date:
06/4/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
