Associate Project Manager - Clinical Pharmacology
Location: Daytona Beach
Posted on: December 9, 2018
Job Overview Oversees and manages Clinical Pharmacology and Early Phase Clinical trials at Covance Clinical Research Sites and external sites. Responsible for project and data management activities in healthy volunteer and patient studies including full-service offerings as well as stand-alone services. Responsible for management of single or multiple moderately complex trials managing vendors and sites in studies of varying financial value. The Project Manager will be primary client contact and responsible for the facilitation of communication, managing client expectations, and building business relationships.
- With mentorship from a more senior Project Manager as needed, acts a single point of contact for the client and project team on single service Covance clinic, external clinic or CDARO projects and/or low complexity full service trials of moderate value.
- Communicates on a regular basis with assigned clients regarding project needs and project status. Facilitates and coordinates communication between client project team members and Covance project team members.
- Liaise with and lead a project team, including but not limited to Covance Site CRC, Data Management & Reporting team, CRA, and vendors (both internal and external) regarding project specific requirements and scope.
- Serve as the escalation point for project issues.
- Manages scope of the project by reviewing proposals and budgets, identification and submission of work scope changes against the project timelines, and on time delivery of project deliverables.
- Responsible for the review and assessment of ongoing hour/budget utilization throughout the course of project to ensure that the projects are meeting financial targets.
- Collaborate with finance when project milestones have been met to initiate monthly invoicing, as appropriate.
- Report client and department project metrics, maintain baseline information and assist in the compilation of manual data. Implement mitigation plans where variance occurs.
- Performs overall management of the project or program timelines through use of MS Project and ensuring that changes or updates are made in a timely manner. Renegotiates timelines with client and project team as necessary.
- Create required project plans. Implement and monitor progress against project plans and revise as necessary.
- Track project metrics. Monitor and report on KPI for strategic relationships.
- Accountable for client eTMFs including eTMF Index & Plan, uploading project management documents, review and QCing of project documents and timely delivery of the eTMF per the agreed upon timelines.
- Identify project risks and mitigation strategies. Ensures project team members are informed of problems that may affect the project performance.
- With support from a more senior level Project Management position as needed, monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.
- Seek out lessons learned to apply to project risk plan.
- Liaise with Quality assurance regarding regulatory compliance of study reporting and Sponsor audits
- Assist in ensuring that all staff allocated to assigned projects adheres to professional, SOP, and specific GCP and ICH standards.
- Follow defined project issue escalation process and Covance's CAPA and Corrective Action Issue Resolution (CAIR) process.
- Ensure that internal project review meetings are conducted as needed. Depending on size and scope of project, lead meetings as appropriate.
- Organizes, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes and follows up on Action/Decision/Issues (ADI) items.
- Meet/exceed client satisfaction expectations.
- Develop a detailed understanding of clinical, data management, reporting, and critical path activities.
- Contribute and participate in the delivery of presentations for senior management as required.
- Increase potential for repeat business buy establishing working relationship with client project team and client satisfaction and operational excellence.
- Participate in bid defense and other business development activities.
- Perform other duties as assigned by management. Education/Qualifications
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Acceptable: In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Working knowledge of ICH Guidelines and GCP including a basic understanding of international regulatory requirements for the conduct of clinical development programs.
- Working knowledge of the drug development process. Experience
- Preferred: Certified in Clinical Research - SOCRA/ACRP Certification
- Working knowledge of Covance SOPs.
- Minimum of four (4) years of relevant clinical research experience in a pharmaceutical company/CRO including study management and/or study/project coordinator experience.
- Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, clinical supervision, data management, clinical study management, clinical monitoring, and clinical project management may be considered.
- Working knowledge of applicable regional regulatory requirements.
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Working knowledge of drug development process and client needs.
- Good communication, planning and organization skills.
- Good computer skills with good working knowledge of a range of software packages.
- Ability to understand and work with financial information.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Ability to work within a project team
- Ability to liaise with clients in a professional manner
- Ability to work efficiently and effectively in a matrix environment. Preferred:
- 1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- Local project coordination and/or project management experience.
Keywords: Covance, Daytona Beach , Associate Project Manager - Clinical Pharmacology, Executive , Daytona Beach, Florida
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