Clinical Research Manager
vor 2 Monaten
Job Description
The primary function of the Clinical Research Manager position 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 to be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.
The Clinical Research Manager acts primarily as clinical study team leader and has overall responsibility for a study. Specifically, the CRM has the following tasks and responsibilities:
Responsibilities:
- Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements. This includes 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.
- Ensure compliance of the study with GCP, applicable legislation and our Company's policies and procedures.
- Plan and coordinate the monitoring and data management activities of each study.
- Prepare the Final Study Report.
- As GMP Study Product Manager ensure GMP compliant labelling of Clinical Trial Material
- Prepare critical summaries and expert reports to management and/or for submission to regulatory agencies
Requirements:
- A Doctor of Veterinary Medicine, OR equivalent veterinary degree (An advanced degree e.g. PhD desired)
- A minimum of four years of experience in clinical research or similar research role.
- Strong scientific writing ability.
- Good communication skills, excellent English language proficiency (C1) every other European language is a plus
Our Benefits
- Varied areas of responsibility
- Contributing your own ideas to the process design
- Collaboration in the development of veterinary medicinal products
- Insights into the workings of a large company
- Numerous training and further education opportunities
- Small site in a beautiful location with a family atmosphere
- Payment according to collective agreement, long-term account, company pension scheme
- Hybrid working model with with up to 50% home office and presence at the Schwabenheim site
- Own canteen
- Health support (massages, health day, resources for living)
- Company bike, corporate benefits, (electric) car parking spaces
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
N/AJob Posting End Date:
08/3/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R303568
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