Website HengRui USA
HengRui USA is the US hub for our parent company Jiangsu Hengrui Medicine (600276 SHA), a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. The product line includes antineoplastic drugs, angiomyocardiac drugs, surgical drugs, contrast agents and antibiotics. The pipeline across different therapeutic areas such as oncology, autoimmune, pain management, metabolics etc.
In HengRui USA, we recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want you to feel empowered to do your best work, in a place where you are respected, engaged, fulfilled, and developing!
Clinical Study Manager – Remote
Location: Remote, NJ
Reports to (Title): Study Management Head
Department: Clinical Operations
Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more therapeutic areas, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines; will manage and be responsible for all activities related to global and/or local clinical trials from the study start up to the clinical study research report; Lead the Study Team; Contributes to the Study Concept development with regard to operational aspects; develops the comprehensive overview and operational plans for the study.
The Clinical Study Manager will oversee and manage all operational aspects of phase I – IV clinical trials with minimal oversight across all therapeutic areas to achieve a high-quality product for the marketplace and business success for HengRui. As a Study Manager, you are responsible for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies.
Essential Job Functions:
Study Management & Leadership
- Ability to manage studies using an in-house model
- Reports on key study performance information and cycle time metrics pertaining to time, cost and quality deliverables, e.g. study start-up metrics, enrollment, data collection timeliness, etc.
- Leads the development of the clinical study plan including critical path activities and interdependencies for assigned clinical study utilizing Microsoft Project or equivalent.
- Provides operational input into study protocol profiles, final protocols, informed consent and amendments
- Proactively assesses potential risks to the study and proposes risk mitigation plans.
- Provides study specific oversight and leads collection of site feasibility data, enrollment projections and site identification activities. Oversees the site qualification process.
- Develops and drives study timelines, milestones, site and study level budgets and accountable for providing monthly and yearly financial estimates. Responsible for tracking study budget and payments and forecasting study spend.
- Reviews and approves site and vendor invoices, including investigator grants and pass through costs.
- Assists in the development of the core study documents, plans and processes.
- Assists in the preparation of the study protocol operational elements.
- Verifies that all relevant IT-systems are updated with current and accurate information (e.g. CTMS, eTMF).
- Responsible for oversight of TMF with periodic audits
- Ensures regulatory and GCP compliance
- Plans and coordinates IMP and non-IMP supplies
- Contributes to development of proactive strategies and corrective action plans as needed to address study issues
- Identifies, implements, leads and manages a cross-functional core Study Team for the duration of the study, working with management to identify team members and resolve issues and disseminates relevant information to team members in effective and timely manner.
- Triages, resolves and/or escalates study issues /risk mitigations to Study Management Head.
- Ensures adherence to internal procedures for study planning, study conduct, close out and reporting.
- Has routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries
- Responsible for the oversight, performance, and management of vendors (if needed) to ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
- Responsible for ensuring that vendors provide timely input and generate documents in a timely manner and with quality.
- Responsible for overseeing study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversees and tracks site initiation and enrollment activities at the country and site level and develop mitigation strategies.
- Coordinates, prepares for and executes meetings including but not limited to team meetings, investigator meetings and training.
- Helps to ensure team and external partner(s) receive and document study specific training
- Other tasks as assigned
Experience / Education
- A Bachelor’s degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- 7 – 8 years of relevant healthcare experience and 3 years clinical operations experience in the Pharmaceutical Industry
- 1 – 2 years of Monitoring and/or Clinical Trial/Study Management experience preferred.
Knowledge / Skills / Abilities:
- Knowledge of all phases of drug development: Phase I – IV global clinical trials across multiple therapeutic areas
- Extensive and comprehensive knowledge of Good Clinical Practice (GCP), Federal Regulations and International Regulations (International Harmonization Committee-ICH Regulations).
- Oncology experience and project management PMP certification is preferred
- Maintains current medical/scientific/regulatory knowledge.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills.
- Maintains computer literacy in appropriate software
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability