Associate Director Clinical Operations
Proclinical is currently recruiting for An Associate Director of Clinical Operations for a leading biotechnology company located in Somerset, NJ. As the Associate Director, you will be responsible for all aspects of study conduct and CRO oversight and a point of contact for clinical study project management, communications, and daily operations.
- Ability to manage and collaborate on complex protocols within a matrix environment (Data Management, Safety, outsourcing and vendor alliance management)
- Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines
- Report on all aspects of the study progress at a granular level to Operations management. Effective, consistent & regular tracking of project (s)
- Provides study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel
- Collaborates with following groups across the trial program: Data Management, Statistics, Clinical Supplies, Safety, etc
- Collaborates in the writing and review of study protocols, informed consents and amendments
- Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs
- Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities
- Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Excellent team player; willingness and ability to fill functional gaps in a small organization
Skills and Requirements:
- Bachelor's Degree is required, preferably in scientific or health care discipline
- 8+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
- CRO oversight experience required
- Project Management (CRO/biotech) experience a plus
- Demonstrated ability to multi-task and manage high performance demands
- Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Regulatory authority inspection experience a plus
- Effective oral, written and interpersonal communication skills.
- Strong communication skills
- Sop development experience preferred
- Strong organizational and project management skill and the ability to multitask
- Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project)
- Oncology Therapeutic Experience preferred
- Excellent working knowledge GCP, FDA and ICH Guidelines
- Ability to travel as necessary (approximately 10 - 15 %)
If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.