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Senior Scientist – Clinical Trials
vor 1 Monat
Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra
Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of over 2500 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
The Opportunity
The primary function of the Senior Scientist (Clinical Trials Manager) position is to coordinate and oversee all aspects of Dechra's clinical studies in support of global product registrations. With support from Management and other Clinical Trials Manager(s), the Clinical Trials Manager ensures that studies are conducted in accordance with the scientific design and timelines provided by the Efficacy Lead and are in compliance with applicable requirements, including Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements/guidelines (e.g., Good Clinical Practice). The Clinical Trials Manager is supported by internal Study Monitors, Clinical Data Managers, and administrative staff along with external contract resources as needed.
Main Responsibilities
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- Assist Efficacy Leads in designing clinical studies.
- Draft protocols together with the Efficacy Leads and Biostatistician and facilitate protocol review, submission for concurrence (if applicable), revision, and finalization.
- Collaborate with Monitors to ensure appropriate clinical study site selection, qualification, and training.
- Selection and coordination of central laboratory for clinical pathology and other external vendors, as applicable.
- Work with Clinical Data Manager to ensure creation of a robust Electronic Data Capture database for clinical studies.
- Create clinical study site budgets and approve study-related invoices.
- Establish contracts with clinical sites and other vendors.
- Work with clinical supply coordinator to organize IVP/CP supply for studies.
- Oversight of study monitoring in managed studies and review of key study data following site close-outs.
- Act as Monitor for clinical study sites on an as-needed basis.
- Provide technical and scientific support to members of the Product Development organization as needed.
- Work with Clinical Operations personnel on the creation and implementation of policies and SOPs related to clinical studies.
- Work with Clinical Operations management to implement new processes and technologies related to study execution and oversight.
- Oversee data cleaning and database lock.
- Update Efficacy Leads on study status.
Ideal Candidate:
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:
- A degree in relevant discipline or equivalent professional experience.
- Strong analytical & organizational skills with the ability to handle multiple tasks and prioritize.
- Ability to communicate effectively with excellent written/verbal skills.
- Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, and report writing.
- Experience in management of veterinary clinical studies or extensive experience in monitoring clinical studies with experience as lead monitor in at least 1 study.
