Project Manager
hace 3 semanas
As a Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- Provides Project Oversight & Leadership for Clinical Deliverables:
- Leads and manages the start-up and clinical teams.
- Plans and leads execution of day-to-day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations, and status updates.
- Vendor management and budget management, if required
- Works with the team to set priorities.
- Leads and supports the relevant staff (ie, local start-up staff, local and global regulatory affairs staff, in-house clinical staff, etc) to drive successful activation of trial sites.
- Motivates the clinical team.
- Ensures effective communication and escalation plans are place for the clinical team.
- Facilitates cross-functional team communication for proactive, study-wide problem solving regarding study progress and trial issues during the study.
- Monitors the quality of clinical activities and addresses quality issues with the appropriate team member.
- Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up, and resolution of site issues.
- Identifies opportunities to improve training, execution, and quality control across the team.
- Liaises with relevant staff to provide data, as required, for clinical operations performance metrics and project status metrics.
- Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
- Quality - Training & Development:
- Creates and maintains project-specific plans, documents, and tools for the clinical team.
- Plans, oversees, and conducts initial and ongoing training for the relevant study staff on clinical project specifics.
- Analyzes data related to sites activation, monitoring, data retrieval, and close out to identify issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks; communicates risks and mitigation strategies.
- Supports the CRAs with site monitoring activities and provides suggestions and solutions to site issues, as applicable.
- Ensures all project reporting systems are up to date for clinical activities at the project level.
- Oversees the relevant start-up, regulatory, and in-house clinical staff to ensure all initial or amended trial information is submitted, approved, and filed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
- Oversees the relevant regulatory and in-house clinical staff to ensure that all non-safety periodic updates, progress reports, and renewals, and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH GCP, and any other processes or procedures governing the clinical trial.
- Identifies metrics and trends across team members, countries, regions, and uses the information to promote improvement in quality and consistency of execution.
- Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventive action (CAPA) plans, responds completely and accurately to audit reports, and provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses.
- Organizes project-specific compliance plans for key processes, tools, and systems.
- Reviews filing of Essential Documents in the electronic Trial Master File (eTMF) to ensure sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH guidelines.
Capabilities:
- Ability to lead cross-functional team - set priorities and performance targets in a global environment; effectively plans, co-ordinates and facilitates delivery of study team objectives; understand the accountabilities of study delivery team members and engage & use them to optimum effect; provide the leadership to enable a high performing team.
Creative thinker - able to modernize approach to study delivery
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
Effective problem solving and conflict resolution skills with a solutions-oriented mindset
Appropriate project management skills
Operational expertise in risk management and contingency planning
Strong influencing and stakeholder management skills
Ability to create a trusting partnership with Clinical science discipline and all study team members
Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Ability to understand and balance the broader business needs with the needs of their specific study
In addition, in outsourced studies:
- Ability to challenge current process to drive towards efficient
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