Balsam Clinical Research is Looking for a Clinical Operations Manager
The Clinical Operation Manager role shall support the development and execution of the Clinical Operations infrastructure to ensure high quality standards and timeliness of implementation and completion of clinical trials. The Clinical Operation Manager shall oversee operational aspects of all clinical studies within assigned territories and/or worldwide and provides strategic direction for clinical trial operations through the direct line-management of the clinical research staff. The Clinical Operations Manager is responsible for the development and implementation of clinical research processes and systems.
Location: Saudi Arabia
Principal Duties and Responsibilities:
– Direct, manage and mentor an assigned team of clinical staff.
– Actively provide guidance/coaching around project planning, project review, risk management and problem solving to achieve global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.
– Oversee project deliverables to exceed customer expectations and identify/convert new business opportunities; provide consultation to clients on drug development process, strategy, and plans as needed.
– Oversee the activities of the Clinical monitoring team to support overall project management timelines:
– Work with direct reports and project teams within oversight remit to ensure financial discipline and achievement of corporate financial objectives as well as system/process compliance.
– Serve as principle point of escalation for project and program teams within oversight remit, providing effective and timely consultation/guidance to ensure issues resolution.
– Support in completing RFIs, budget development and attend bid defense meetings as well as project resourcing activities; participate in and champion function and/or corporate initiatives, changes and/or special projects.
– May serve as a back-up on projects as needed.
– Manage interactions with outside consultants, vendors and other groups.
– Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, assuming appropriate managerial oversight of CRA staff, establishing co-monitoring procedures, and ensuring that cleaned data are entered into the database in a timely manner.
– Responsible for implementation of all QC procedures in reference to Balsam CR SOPs.
– Responsible for CAPA implementation in reference to Balsam CR SOPs.
– Provide support as needed for development of new Balsam CR documents including but not limited to SOPs, Procedures, Policies…..etc.
– Review and approve monitoring visit reports, regulatory documents, and other key study records.
– Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed.
– Assist in the preparation of protocols and Case Report Forms, monitoring and data management tools and other study documents.
– Bachelor’s degree in life sciences or related field and at least 3 years of clinical research experience
– Current presence in Saudi Arabia
– Fluency in Arabic as a mother tongue, besides English. A third language is preferred.
– In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
– In-depth understanding of project management practices and strong history of demonstrated project management capabilities.
– In-depth understanding of, and experience managing, contractual obligations and implications.
– Demonstrated strong understanding of project financials and managing P&L
– Proven ability to manage a team and work through others in a global environment to deliver results to the appropriate quality and timeline metrics. Provides others with a clear direction; delegates work appropriately and fairly; motivates and empowers others; monitors/manages performance and provides feedback and coaching; recruits, develops and retains staff of a high caliber.
– Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers; and negotiate solutions.
– Strategic vision and skill in securing and expanding business.
– Ability to manage competing priorities.
– Good judgment and decision making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
– Strong presentation skills.
– Strong software and computer skills, including MS Office applications
Interested candidates can send their CVs on: firstname.lastname@example.org
Only candidates with the above requirements will be considered