Njehnu Outance
Sr Clinical Project Specialist
Berlin,BE
Summary
Resourceful clinical Project Management with 5 years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Knowledgeable in accounting principles, bookkeeping, budget, and financial management. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
14
14
years of professional experience
2
2
Languages
Work History
Acting Vendor Project Manager
Syneos Health / Farnborough
8 2023 - Current
- Interacts with project teams, sponsors, and vendors to define scope of services for vendor technologies
- Responsible for directly project managing the overall implementation and ongoing oversight of Eleven vendors assigned projects
- Oversees all vendor activities from assigned study vendors to ensure timelines and quality standards are met, including day-to-day vendor activities from start-up to close out such as timeline management, vendor contracts management, and invoicing review
- Responsible for overseeing the implementation of vendor systems into production at start up till study closure.
- Fostered lasting relationships with customers through effective communication and quick response, resulting in long-term loyalty and expanded client base.
- Developed long-term strategic partnerships with key vendors, enhancing collaboration and creating mutual benefits.
Sr Project Specialist
Syneos Health / Farnborough
01.2019 - Current
- Manage the maintenance and coordination of the logistical aspects of clinical projects and provides overall support to functional leads to ensure the successful completion of project deliverables
- Collaborate with the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements
- Operate independently, with minimal day to day oversight, and co-ordinate the activities of Project Specialists and other clinical support team.
- Identified potential roadblocks early in the planning phase through diligent research, allowing time to develop contingency plans effectively.
- Optimized budget allocation by diligently tracking expenses and reallocating funds as needed based on priorities and progress updates.
- Maintained open communication by presenting regular updates on project status to customers.
- Led change management efforts to minimize resistance from stakeholders during critical transition periods in projects.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
Clinical Projects Assistant II
Synteract Ltd / Ely, Cambridgeshire
04.2018 - 12.2018
- Assists study teams with all aspects of trial management from start-up to close-out on one or more studies
- Maintains and updates project-related data in an existing database i.e
- CTMS, EDMS, eTMF etc., which involves contacting internal team members to gather information
- Also assist with preparation of Status Reports for the study team, sponsor and study related parties
- Creates the Trial Master File (TMF) and/or Investigator site files; supports maintenance for the duration of the study, assisting in the file review and reconciliation process in preparation for audits and archival
- Ensures finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site
- Prepares and contributes to study related correspondence, including but not limited to: meeting minutes, tracking spreadsheets and presentations.
Clinical Projects Assistant
GW Pharmaceuticals / Cambridge
04.2017 - 04.2018
- Set-up and Maintain Trial Master Files for the duration of the study
- Providing support to the Clinical Operations Managers, clinical Projects Managers and Clinical Research Associates throughout the lifespan of the clinical trial
- Review, audit and resolution of trial master files across for MHRA and FDA inspection
- Perform quality control of investigators sites over five countries in preparation of regulatory inspections
- Coordination and tracking of clinical projects on a global scale
- Provide support to the clinical coordination department
- Development, implementation and maintenance of trial logs
- Coordination of regulatory submissions (tracking of approvals process)
- Preparations of Clinical Trials Agreements and financial agreements in liaison with the contract coordinator.
Clinical Research Assistant
NHS Foundation Trust/ Harrogate
04.2016 - 04.2017
- Provide support to the investigators during evaluation and recruitment process
- Maintain documentation from pharmaceutical companies and regulatory authorities to make sure the research is conducted within the good clinical practice rules
- Ensure correct reporting and documentation of adverse events and any deviations from research protocol
- Coordinate different clinical studies including, investigational medical products, investigational devices, observational studies and safety studies on already licensed products
- Transcribe information from source documents to electronic case report forms.
Mental Health Worker
NHS Professionals / London
04.2010 - 04.2016
- Working with the aim to assist mental health clients to rehabilitate themselves and to gain as much independence as possible
- Working directly with service users in a safe secure environment, to provide therapeutic interventions and assistance to those affected by various mental health and learning disabilities
- Carrying out different levels of clinical observations and assessments stipulated by the mental health act.
Education
Masters - Medicinal Chemistry
Open University - United Kingdom
Bachelor - Bio-Chemistry
Texas Woman's University - United States
Skills
Attention to Detail
Analytical Thinking
Self Motivation
Continuous Improvement
Relationship Building
Customer Needs Assessment
Contract Negotiation
Problem-solving aptitude
Team building
Professional Certifications Licensures
Syneos Health Project Management Development Program - Apr-2023 to Oct-2023
Therapeutic Experience
- Non-drug Interventional studies
- Cardiovascular - Heart Failure
- Cardiovascular - Hypertension
- Device - Blood Glucose Monitoring Device
- Device - Diabetic Neuropathy Device
- Device - Insulin Pump Device
- Neurology - Alzheimers Disease
- Neurology - Dementia
- Neurology - Dravet Syndrome
- Neurology - Epilepsy, Lennox-Gastaut
- Neurology - Epilepsy, Partial-onset Seizures
- Oncology - Cancer, Glioma
- Oncology - Cancer, Sarcoma
- Ophthalmology - Diabetic Retinopathy
Accomplishments
- Supervised team of 8 staff members.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Achieved three successful FDA inspection through effectively helping with clinical documentation compliance.
- Documented and resolved vendor and project delivery issues which led to successful closure of five projects.
Timeline
Sr Project Specialist
Syneos Health / Farnborough
01.2019 - Current
Clinical Projects Assistant II
Synteract Ltd / Ely, Cambridgeshire
04.2018 - 12.2018
Clinical Projects Assistant
GW Pharmaceuticals / Cambridge
04.2017 - 04.2018
Clinical Research Assistant
NHS Foundation Trust/ Harrogate
04.2016 - 04.2017
Mental Health Worker
NHS Professionals / London
04.2010 - 04.2016
Acting Vendor Project Manager
Syneos Health / Farnborough
8 2023 - Current
Masters - Medicinal Chemistry
Open University - United Kingdom
Bachelor - Bio-Chemistry
Texas Woman's University - United States