Note: The job is a remote job and is open to candidates in USA. Worldwide Clinical Trials is a global midsize CRO focused on innovative approaches to clinical research. The Senior Director of Clinical Projects is responsible for overseeing clinical activities, leading departmental initiatives, and ensuring compliance with regulatory guidelines while managing a clinical team.
Responsibilities
- Engage with senior management to establish strategic departmental initiatives and objectives
- Accountable for clinical team key performance indicators (KPIs) and associated metrics
- Drive identification of process improvement needs and coordinate initiatives to support these activities
- Lead new quality management document (QMD) developments, including authoring and reviewing QMD and guidance documents
- Create and lead CAT committees to further initiatives
- Actively participate in the identification and development of new service arms
- Actively participate in the improvement of existing service arms
- Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities
- Participate in internal and external marketing activities
- Serve as an external spokesperson for CAT
- Provide oversight, training, and support for the clinical team
- Actively engage in the protocol development process, including research, literature review, assessment review, and risk assessment
- Identify clinical needs for upcoming and current projects, and track and review them with CAT Clinical Staff and Leadership
- Resource CAT study projects as Resource Manager
- Accountable for all contracted clinical activities in clinical trials
- Provide clinical expertise and review of clinical plans and training content for CAT-awarded trials
- Oversee development of assessment training content and plans, ensuring training curriculum and materials (including videos) meet protocol, copyright holder, author, and sponsor requirements
- Serve as Subject Matter Expert (SME) for CAT clinical activities, including therapeutic area and assessment advisement and guidance
- Provide clinical expertise on measurement administration and scoring conventions
- Support scale acquisition activities, including scale versioning
- Accountable or consulted, depending on study assignment, on source document creation to ensure materials align with study protocols
- Lead development of data surveillance plans and oversee execution of data surveillance throughout trials
- Accountable for CAT sponsor and team reports
- Manage clinical staff directly
- Lead vetting, hiring, and onboarding of new clinical staff
- Oversee coordination and execution of onboarding and mentoring assignments
- Oversee CAT study deliverables from launch through study closeout
- Ensure CAT Clinical staff operate in a constant state of inspection readiness
- Contribute significantly to strategic departmental, sponsor-related, and cross-functional initiatives
- Collaborate with CAT staff, Project Management, and Contracts on study budget development, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms
- Drive research activities, including data analysis, white papers, posters, and related contributions
- Apply advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial conduct
- Perform other duties as assigned
Skills
- Master's degree in life sciences or equivalent
- At least 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators' Meetings or similar forums as an expert clinician
- Strong applied knowledge of pivotal efficacy measure administration conventions and the ability to train assessors
- Knowledge of operational aspects of Phase I–IV clinical research trials and experience working with a Contract Research Organization or Rater Training Organization
- Excellent collaboration skills and ability to work cross-functionally to drive projects and initiatives
- Strong problem-solving and critical thinking skills
- Demonstrated ability to apply knowledge and utilize resources to develop new ideas and improve existing processes
- Excellent knowledge of SOPs, ICH/GCP, and regulatory guidelines
- Competence in working with data and numerical analysis
- Fluency in English, including reading, writing, and speaking, for daily business operations
- Ability to travel domestically and internationally to attend key meetings, with flexibility to accommodate global time zones as needed
- Preferred minimum of 4 years of experience managing team members or providing direct clinical mentorship
Benefits
- In addition to base salary, we offer a competitive benefits package depending on location.
- We ensure pay equity and transparency and comply with all applicable labor laws.
Company Overview
Company H1B Sponsorship