Note: The job is a remote job and is open to candidates in USA. Bioventus develops orthopedic devices and biologics intended to help patients resume and enjoy active lives. The Clinical Program Manager will plan, initiate, and execute regional and global clinical studies and projects while managing scope, timelines, budgets, quality, regulatory compliance, study teams, sites, and vendors.
Responsibilities
- Establish the study/project team goals and lead each phase of the life cycle of the assigned studies/projects to ensure completion in compliance with Bioventus SOPs and applicable GCP/ICH guidelines and other regulatory requirements
- Provide accurate and up-to-date study/project information and metrics to management; proactively identify and resolve issues that arise during regional and global study conduct; manage escalation of study/project-related issues
- Study Documents: accountable for all study documents for assigned studies/projects; and may assist with preparing key documents such as, ICF Investigator Brochure, FDA Briefing Documents, internal/external presentations, etc., develop and approve study plans
- Assist the Director Clinical Affairs in protocol development including but not limited to review of relevant literature, liaison with external subject matter experts, and drafting of initial versions. Monitor study/project execution against protocol intent and suggest amendments as necessary with contribution toward development of desired amendments
- Oversee the financial life cycle of the study execution including site budgets, study budgets, study forecasting and invoice reconciling. With reporting and tracking of study financial activities from patient, site, and vendor details via the use of CTMS and/or Excel files
- Contribute insights with respect to timely data cleaning, data analysis and the availability of top line results through liaison with the Data Manager and the Director Clinical Affairs; and participate in data reviews
- Lead effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
- Perform site visits to conduct training as needed. Prepare protocol training slides for use at site initiations and investigator meetings
- Successfully execute Investigator Meetings or site initiations
- Contribute to vendor selection and oversee CRO monitoring for outsourced activities
- Oversee appropriate communication, reporting and documentation of adverse events and protocol deviations per investigational plan, Bioventus SOPs, and regulatory guidance
- Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets and files) via the eTMF and CTMS system
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study deliverables
- Lead feasibility assessment and selection of countries and sites for study conduct; conduct site assessment visits in conjunction with team members as needed
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data. Periodically review and lead changes in SOPs to ensure fitness for purpose and compliance with applicable regulations
- Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with regional and global vendor study team
- Review and approve vendor user requirement specifications for systems, devices and associated paraphernalia utilized in assigned study(ies)
- Provide oversight and direction to study team members for study deliverables, study start up and oversight: Accountable for the identification, bid process, and final selection of vendor(s), oversee vendor identification and activities
- Proactively resolve issues in a timely fashion, establish strategies for the collection of data, selection of sites, issue identification, monitoring and investigator communications
- Lead cross-functional study teams, including regional and global vendors
- Responsible for study level supplies and investigational product/device/investigational material accountability, including selection and management of vendors
- Contribute to the oversight and implementation of risk management and mitigation activities. Manage and implement appropriate matrix team communication for escalation of risks and compliance
- Lead, manage, and mentor direct report study team members actively providing educational and developmental opportunities, performance goals setting, periodic assessments and associated administrative activities
- Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role
- Other duties as assigned
Skills
- BA/BS degree in Life Sciences or related field
- Minimum 8 years of clinical trial experience with at least the two most recent years in a people management role
- Must have strong knowledge of ICH/GCP and relevant 21 CFR requirements
- Must have strong knowledge of protocol and clinical development processes, clinical study design, study planning and management, and monitoring
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
- Must have a good working knowledge of medical terminology, anatomy and physiology
- A detail-oriented, self- starter who is comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
- Requires proven effective leadership
- Master's level education preferred
- Medical Device experience is highly preferred
Company Overview
Company H1B Sponsorship