Study Manager

Health Care/Medicine jobs >> Pharmaceutical

Negotiable

Permanent

Description

My Clients metabolism team is their global centre of excellence for drug and environmental metabolism.

They partner with their clients to provide solutions in characterising a drug candidate’s ADME properties, kinetics, bioavailability and safety, as well as determining the fate of molecules in the environment and identifying the nature of residues in livestock and crops.

A passionate business with a strong appetite for growth and innovation, they are proud of their achievements to date and excited for what the future brings.

The purpose of the role is to study direct environmental fate and plant metabolism studies for new product development in compliance with global regulatory requirements.

Key Roles and Responsibilities:

• Act as Study Director on environmental fate and plant metabolism studies.

• Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in study plan.

• Plan work to ensure revenue recognition milestones on assigned studies are achieved and ensure resource allocated to studies is effectively utilised

• Prepare study plans, amendments, file notes and deviations, as required.

• Prepare worksheets to coordinate experimental activities.

• Calculate and QC check data.

• Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports

• Prepare study reports.

• Address findings arising from QA audits and process inspections.

• Effectively communicate with clients regarding study progress and address client comments.

• Supervise, mentor and/or train more junior members of staff.

• Review cost builds for assigned studies with Team Leader, track actual vs budgeted hours providing feedback where changes to cost builds are necessary.

• Ensure potential work scope changes are flagged to management.

Qualification

• PhD, MSc or BSc (Hons) in chemistry, biochemistry or related subject

• Experience working in an environmental fate and plant metabolism laboratory

• Experience with study directing at a GLP facility

• Experience working with Radioactivity (14C /3H)

• Deep knowledge of environmental fate & plant metabolism

• Understanding of the drug and/or agrochemical development process

• Proficiency in analytical techniques (HPLC/TLC/LC-MS)

• Project management

• Scientific data interpretation, reporting and presentation skills

• Excellent oral and written communication skills

• Strong organisational, prioritising and scheduling skills

• Problem solving
  • 1
  • Negotiable
  • None
  • None
  • CV-123376
  • Permanent
  • 9

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