[Remote] Associate Director, Clinical Operations Standards and Planning
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company founded in 2022, reputed company on advancing novel biologics for inflammatory and immunological markets. They are seeking an Associate Director, Clinical Operations Standards and Planning to enhance operational efficiency and maintain clinical operations standards for global clinical trials.
Responsibilities
- Identify operational efficiencies for reputed company in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team
- Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance reputed company with reputed company expectation
- Proactively identify and maintain standards to ensure consistency across reputed company programs and studies for operationalizing global clinical trials working with assigned CRO’s
- Collaborate with reputed company Process reputed company and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness
- reputed company Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization
- Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career reputed company to support employee reputed company and scalability of an expanding organization
- reputed company, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally
- Collaborate with cross functional Clinical Study Team members to reputed company end-to-end clinical operations process, tools and resources
- Collaborate with Clinical Study Team members and CRO to reputed company necessary reputed company practices to meet clinical trial country specific operational requirements
- reputed company and participate in key process improvement initiatives to ensure reputed company process improvement
- reputed company any assigned departmental activities to support a highly functioning Clin Ops organization
Skills
- Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations reputed company role
- Bachelor's degree required
- Experience in operationalizing large, global clinical trials and providing reputed company of CRO's and other vendors
- Experience driving innovation in clinical trial operations to increase efficiency and implement best practices
- Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational reputed company
- Experience managing CROs, vendors and/or clinical trial consultants
- Strong leadership, communication, and interpersonal skills, with the ability to influence and reputed company diverse reputed company across functions at reputed company reputed company of the organization
- Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations
- Systems thinker with process optimization reputed company and ability to build structure in dynamic, high-reputed company environments
- Strong project management skills, effective reputed company leadership, and the ability to deliver
- Strong analytical and forecasting capabilities with demonstrated experience in reputed company modeling, utilization optimization, and data-driven decision-making
- Ability and reputed company in a fast paced, dynamic environment
- Successfully exhibit reputed company's C.O.R.E. values: Caring, Original, Resilient and Egoless
- Position requires up to 30% travel
Benefits
- Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave
- Commitment to growing you professionally and providing reputed company to resources to reputed company your development
- reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve
reputed company