Clinical Research Manager- FSP

Résumé du poste

The Clinical Research Manager is accountable for end-to-end project management and performance of assigned protocols in compliance with ICH/GCP and country regulations. This includes acting as the main point of contact between country operations and clinical trial teams while managing site selection, recruitment, and closeout.

Détails du poste

Parexel FSP is looking for a Clinical Research Manager! Job Purpose The Clinical Research Manager (CRM) is responsible for the following: Primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, could be responsible for several countries in a cluster. Supporting Activities- May include but not limited to the following: Study Management Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT) Responsible for project management of the assigned studies: Proactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and closeout Accountable for performance for assigned protocols in country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally Performs quality control visits as required. Reviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to Clinical Research Associate Manager and /or functional vendor and internal management as needed Leads local study teams to high performance: Trains in the protocol for other local roles. Collaborates with and supports Clinical Research Associates as protocol expert. Coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinator (CTC), Clinical Research Associates (CRAs), and Clinical Operations Manager (COM) Responsible for creating and executing a local risk management plan for assigned studies Ensures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and/ or CTT (as appropriate) Identifies and shares best practices across clinical trials, countries, clusters. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies Country Point of Contact for programmatically outsourced trials for assigned protocols As a customer-facing role, this position will build business relationships and represent Client with investigators. Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets) Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA Head and Regional Operations Team development and support Leads and contribute to initiatives and projects adding value to the business and supporting the strategy Compliance with Parexel standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, Skills ICH-GCPs and other applicable requirements Strong organizational skills with demonstrated success required Requires ability to make decisions independently while overseeing important activities relevant to clinical research in the country according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Director or CRD Requires strong understanding of the local regulatory environment Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions Ability and skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery Strategic thinking Ability to work efficiently in a remote and virtual environment. Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Client, Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO) Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include low patient recruitment; inadequate staff to meet business needs; performance or compliance issues; working with regulatory issues and the broader organization; and resolution of conflictive situations Understands cultural diversity Proficiency in written and spoken English and local language; must be competent and effective in written and verbal communication Education/pedagogic, diplomatic, and empathetic skills to effectively build and maintain professional relationships with investigators and other external stakeholders Travel expectations is up to 30% of working time Knowledge And Experience 5-6 years of experience in clinical research; CRA experience preferred. Knowledge in Project Management/Site Management with proven strong project management skills and /or project management certification or relevant training program/close mentoring Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics as well as the ability to focus on multiple deliverables and protocols simultaneously Experience functioning as a key link between CO and CTT Education Bachelor’s degree in science (or comparable) required; advanced degree (Master’s degree, MD, PhD) preferred

Ce que vous ferez

The Clinical Research Manager is accountable for end-to-end project management and performance of assigned protocols in compliance with ICH/GCP and country regulations. This includes acting as the main point of contact between country operations and clinical trial teams while managing site selection, recruitment, and closeout.

Exigences

Candidates require 5-6 years of clinical research experience, preferably as a CRA, and a bachelor's degree in science. Strong project management skills and a deep understanding of the local regulatory environment are essential.

Compétences indiquées

• Leadership · Souhaitée
• Gestion de projet · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Project Management
• ICH-GCP Compliance
• Clinical Trial Management
• Risk Management
• Site Management
• Stakeholder Management
• Resource Allocation
• Quality Control
• Regulatory Knowledge
• Conflict Resolution
• Strategic Thinking
• Leadership
• CTMS
• eTMF
• English Proficiency
• Clinical Research

Domaines d’emploi

• Healthcare
• Science & Research
• Management & Leadership
• Consulting
• Manufacturing