Clinical Operations Manager – Consultant
Up to 6 months
Raleigh-Durham, North Carolina / Remote
Our client is a specialist life sciences consulting company that provides product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies. The company has worked with the world’s leading companies, guiding them through their key product development and regulatory decision milestones, from proof of concept to commercialization and post marketing.
What You’ll Do
- Develop and review clinical trial documents, review scientific literature and liaise with external and cross-functional staff in developing clinical study designs/programs.
- Coordinate activities for clinical trials in support of submissions to regulatory agencies.
- Serve as a key member of clients team by developing key performance indicators that follow our client’s objectives and effectively supporting client deliverables and timelines.
- Maintain budgets and timelines throughout the duration of the project.
- Provide cross-functional clinical and ICH support across all sectors, including but not limited to R&D, RA, PV, and RA.
- Prepare scientific conclusions of study results by reviewing and analyzing clinical trial data.
- Conduct studies with associated vendors and supervise the start-up, implementation, conduct and reporting of clinical programs.
- Provide managers with clinical and medical guidance throughout the duration of the clinical trials.
- Serve cross-functionally between various departments as a medical/scientific representative.
- Prepare and oversee clinical documents for IND/NDA/ANDA submissions and support responses to potential FDA deficiency letters.
- Lead discussions and presentations of clinical information and coordinate timelines with internal functions and external stakeholders.
- Maintain professional knowledge of current industry trends and relevant regulations.
- Ensure studies follow GCP/ICH guidelines and are completed in accordance to the investigational plan.
- Bachelor’s degree is required (life sciences degree preferred).
- Significant Clinical Development experience and medical/scientific/regulatory knowledge.
- Minimum of 8 years of experience working in clinical operations for biotechnology/pharmaceutical companies and delivering client advisory information.
- Strong understanding of ICH, GCP and CFR guidelines and experience in a regulatory environment.
- Experience serving as a daily resource for leading projects and engaging with leadership teams.
- Excellent scientific research skills and experience utilizing medical literature and databases.
- Must possess clear and successful management experience in client presentation development and delivery, project planning management, risk/issue management, etc.
- Can resolve routine issues effectively and in line with regulations and company policy.
- Excellent interpersonal written and verbal English communication skills.
- Ability to communicate and develop strong relationships with clients at various levels.
- Strong computer and data technology skills, e.g MS Office Suite, eTMF programs, etc.
- Ability to travel approximately 10% of the time depending on project and client needs.
- Advanced science degree, preferably in pharmacy or medicine
- Experience in leading / supporting business development
- Experience working in Cell and Gene Therapy