Position:

Clinical Operations Lead

Your Key Accountabilities

•         Perform overall management for assigned projects to ensure timely delivery, data quality and budget within control.

- Maintain good communications and relationships with 3^rd party vendors, including but not limited to CRC, CRA, PM or DM/Stats if applicable. 

- Lead internal cross-functional communication to get there, including but not limited to medical, regulatory, CMC, and finance.

- Ensure the clinical trials conduction in compliance with ICH – GCP guidelines, local regulatory requirements, SOPs and protocols.

- Be accountable for project budget preparation, overall tracking of Clinical Trial expenditures and negotiating budgets with 3rd party vendors & investigational sites if applicable.

- Be accountable for overall coordination in project audit & Inspection and ensure complete resolution and closure of relevant findings.

•         Assess project process and initiate improvement as necessary.

•         Provide inputs into SOP development & renewal.

•         Apply industry best practices to the execution of clinical trials to improve time and resource efficiency.

Your Skillset

•        Minimum of 6 years of previous Clinical Operations experience with at least 2-3 years of project management experience or equivalent.

•        Educated to degree level (biological science, pharmacy or other health related discipline).

•        Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

•        Clear and compelling communication.

•        Effective at problem solving and conflict resolution.

•        Operational expertise in risk management and contingency planning.

•        Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available).

•        Competent in reading/written English is must. 

Our Offer:

We offer you an open biotech culture, an exciting journey throughout the world of drug clinical research and development. You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific and management skills, and entrepreneur competency. You can also look forward to a flexible working environment, a pleasant and homelike atmosphere as well as competitive incentive package. If you are looking for a big stage for your profession or beyond, if you are willing to walk out of your “comfortable zone” in your career, come and join us!