(Senior) Consultant Clinical Operations

Company Profile

3D-PharmXchange is a drug development consultancy company located in Tilburg. Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and long-lasting relationships. Our team of experts covers the key areas in drug development of non-clinical, clinical, CMC and regulatory affairs. In addition, we provide project leadership and quality assurance. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia. Our mission is to provide true patient-centered smart expert guidance to support the development of safe and efficacious drugs at the highest quality and cost-efficiency.

Job description

We are looking for a new colleague who can provide clinical operations expertise in support of clinical programs or studies for the development of investigational compounds. As a consultant, you advise and support our clients with the execution and oversight of their clinical studies and/or programs.

Your responsibilities include:

• Support and manage study planning activities, including timelines, budgets, metrics, and risk mitigation.
• Oversee operational execution of clinical trials to ensure delivery on time, within budget, and to quality standards.
• Serve as the central operational point of contact (“spider in the web”) in a cross functional collaborative environment, ensuring alignment across internal team and external partners.
• On behalf of the client act as the primary counterpart for the clinical CRO and ensure efficient working relationships
• Support vendor selection process, and monitor vendor performance and deliverables.
• Provide input to essential study documents, including Clinical Trial Protocols, Informed Consent Forms, and operational plans.
• Support study start-up and conduct activities, including clinical trial registration, eCRF development, data collection oversight, protocol issue management, newsletters, insurances
• Support logistical and operational aspects of meetings (e.g. Investigators’ Meetings, DSMB, advisory boards, KOL meetings)

Requirements

• Relevant academic background in biomedical field.
• A minimum of 5 year experience in biotech/pharmaceutical industry. Experience in small biotech is a pre.
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines.
• Evidence of being able to create, execute and proactively manage clinical processes to ensure quality, timeline, resources, and budget goals are met.
• Experience in Clinical Operations on project/program level (e.g. clinical trial lead, clinical project manager, clinical program manager).
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, flexible and ability to put yourself in the position of our clients
• Be passionate to make a difference in the life of patients and their loved one

Requirements

• Relevant academic background in biomedical field
• A minimum of 5 year experience in biotech/pharmaceutical industry. Experience in small biotech is a pre
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
• Evidence of being able to create, execute and proactively manage clinical processes to ensure quality, timeline, resources, and budget goals are met
• Extensive experience as clinical trial lead
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, flexible and ability to put yourself in the position of our clients
• Be passionate to make a difference in the life of patients and their loved ones

Our offer:

• Be part of a dynamic group of experienced drug development experts
• Enjoy a company culture that prioritizes work/life balance
• Flexible hybrid working options
• We offer strong development pathways and the opportunity to grow into senior roles
• Competitive salary along with a bonus plan, secondary benefits, including pension
• Work alongside a team of friendly and supportive colleague

If you are a proactive professional who loves variety and enjoys working in a non-standard, high-energy setting, apply today!

Send your CV and short motivation letter to Laura van der Hulst, at hr@3d-pxc.com

Acquisition is not appreciated!