Job Reference: J5633463
Updated On: 07/12/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for PK Clinical Study Manager to join a leading Pharmaceutical company based in the Yorkshire area. As the PK Clinical Study Manager you will be responsible for the management of all of the company's Pharmacokinetic (PK) studies at Clinical Trial.
You will use your years of experience and knowledge to be the internal PK expert on all R&D and Clinical projects to support the business needs.
Key Duties and ResponsibilitiesYour duties as the PK Clinical Study Manager will be varied however the key duties and responsibilities are as follows:
1. Study Directing - Manage all interactions with CROs from selection to Study and Protocol design to site visits and audits. You will also manage budgets and review clinical trial data.
2. Pharmacokinetics - Design studies for demonstrating bioequivalence and conduct model dependent and model independent analysis of drug release data. You will work cross functionally to support R&D programme development and will use your knowledge of Clinical PK studies to support the Regulatory team with strategic and timeline planning.
3. Regulatory - Support the development and review of clinical reports for MAAs and NDAs as well as ensure the GCP and ICH guidelines are maintained both internally and by CRO partners.
4. You will provide significant contribution to the R&D teams and key internal stake holders and will have to opportunity to be involved in developing business strategy.
Role RequirementsTo be successful in your application to this exciting opportunity as the PK Clinical Study Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (Chemistry, Pharmacology, Pharmacokinetics, Drug Development etc.) in addition to extensive experience in the field of Pharmacokinetics.
2. Proven industry experience of study design for PK Studies as well as Study Management for clinical studies. This include statistical methodologies for clinical science.
3. Ability to work on a variety of projects concurrently and communicate effectively with internal stakeholders and external collaborators.
Key Words: Pharmacokinetics | PK | Study Director | Study Management | CRO | Clinical | Clinical Trials | Bioequivalence | R&D | Regulatory | Subject Matter Expert
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