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Senior Operations Project
3 months ago
*Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and
You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross-functional team members.
You will assist in the review of clinical study protocols and other study documents, contribute to process development and/or participate in special projects.
Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and bioanalytical strategies in and Collaborative (CO) programs- Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
- Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Primary interface for operational activities between the SMT and laboratory vendors; Provides the day-to-day operational management of vendors to ensure delivery data against contracted scope of work
- Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
- Biomarker Sciences, Vendor Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
- Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains on track
- Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
- Review of relevant documents including protocols, informed consents, and relevant study documents
- Assists in determining the activities to support a project's priorities within functional area
- May contribute or participate in special projects.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support Process development and implementation
- Participates in and manages project meetings and conference calls with vendors and cross-functional teams.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
- Familiar with standard medical / scientific terminology.
