Project Manager Clinical Job Description
Project Manager Clinical Duties & Responsibilities
To write an effective project manager clinical job description, begin by listing detailed duties, responsibilities and expectations. We have included project manager clinical job description templates that you can modify and use.
Sample responsibilities for this position include:
Project Manager Clinical Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Project Manager Clinical
List any licenses or certifications required by the position: PMP, CCRA, PMI, GCP, IATA, LEAN, MS, ACRP, HEDIS, NCQA
Education for Project Manager Clinical
Typically a job would require a certain level of education.
Employers hiring for the project manager clinical job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Life Sciences, Nursing, Healthcare, Education, Pharmacy, Medical, Science, Health Care, Project Management, Life Science
Skills for Project Manager Clinical
Desired skills for project manager clinical include:
Desired experience for project manager clinical includes:
Project Manager Clinical Examples
Project Manager Clinical Job Description
- Experience with clinical data management, technical interfaces, integration and/or interoperability project management
- Provides Project Management training and mentoring within the organization
- Responsibility for leading project teams to deliver assigned projects on-time, on-budget and with the required scope
- Developing cross-functional plans together with the project team including realistic but aggressive timelines, budget and resources planning, risk assessment and contingency planning
- Coordinating resources with Functional Managers and Portfolio Manager
- Acts as information conduit between the Core Team and Sr
- Collaborates and coordinates across all the functional areas (R&D, Marketing, Product Management, QA/QC, regulatory, Legal, Operations, Manufacturing, Service and Support and others) necessary to insure successful program completion and product launch
- Maintaining control over the project by measuring performance and taking corrective or preventive action where appropriate
- Systematically estimate the life-time costs of all relevant studies
- Support staff internally externally addressing client requests and concerns as necessary
- Ability to identify, analyze problems and trends
- Bachelor’s degree in scientific discipline and 4+ years of experience in clinical research
- Knowledge of GCP, clinical trial design, and the overall drug development process
- Demonstrated experience leading trial-related activities such planning, executing, reporting and/or publishing
- Basic knowledge of oncology and/or hematology preferred
- Requires ability to develop strong customer management skills
Project Manager Clinical Job Description
- Keeps project team well informed of changes within the organization and general corporate news as it impacts the project
- Delivers engaging, informative, well-organized presentations and effectively communicates relevant project information to management, stakeholders and team members
- Create and implement timelines and budgets
- Create and consolidate weekly status reports
- Plan and conduct investigator meetings and ad boards
- Prepare the project/monitoring plan for the study/ies
- Previous working experience as a Clinical Applications Project Manager preferred in the Hospital or Health System setting
- 3-5 years of hands on experience implementing Hospital and Office based EHR integration solutions
- Experience working with and coordinating IS, IT and development teams
- Strong experience with budget development and tracking
- A minimum of 3 years hands on accounting experience from Big 4
- Requires knowledge of all internal systems associated with projects
- Requires accredited college, university or recognized professional degree, preferably in a health related field
- Prefer proficiency in appropriate project planning tools
- Some locations require ability to work, on occasion, in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature
- Must be able to lift and carry up to 50 lbs., on occasion
Project Manager Clinical Job Description
- Coordinates the gathering of requirements to define the scope and deliverables of the project in collaboration with leadership, process owners and operational team members
- Anticipates potential schedule or priority delays and initiates plans for alternative actions
- Resolves problems, identifies trends, and determines process/ system improvements
- Coordinates the efforts of the functional departments that instills cross ownership and shared accountability
- Organizes and presents information to foster creative thinking
- Communicates from the top down and bottom up regarding the team responsibilities, target dates, project status, resource needs and provides general project communication as needed
- Fosters clear communication and synchronize activities amount multiple projects and teams
- Possesses strong organizational, presentation and customer service skills
- Identifies best practice solutions and information technology applications/ data structures
- Manages relationships with vendors
- Develop and implement vendor oversight plans for outsourced activities
- Demonstrated experience in study management/monitoring, working and negotiating with CROs
- Demonstrates detailed understanding of clinical protocol, intended study populations solid overall drug development
- BA/BS/Nursing degree or European equivalent education
- BA/B S in related scientific or healthcare field and 6+ years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology and antibody/biologics experience
- Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment
Project Manager Clinical Job Description
- Leads (under oversight of Asst
- Major tasks include staff training, management and oversight of recruitment, assessments, monitoring fidelity and reliability, participating in, and supporting assessments as needed
- Conducts weekly assessments and provides backup support to team for assessments as needed
- Accountable for the writing of clinical protocols and related documents
- Ensure input is provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors
- Accountable for project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country
- Work with PLS Line Functions and QA to identify potential quality issues and implement actions to resolve them
- Be a Suppler Relationship Manager as delegated by the Director SRM for specified CMOs
- Ensure the successful resolution of all issues that may impact timely supply of product and/or contractual obligations
- Develop, gain alignment for and implement project plans
- Bachelor’s degree required or commiserate experience level
- Strong customer oriented mindset Ability to resolve issues with minimal supervision and understand when to escalate
- Comprehensive understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Comprehensive understanding of both site monitoring and study site management requirements
- Ability to lead and develop junior staff
- At least 4 years PM experience with at least 2 years running large, global trials for Sr
Project Manager Clinical Job Description
- Directs the design, documentation, testing and implementation of data collection and database systems for collecting and storing study data for multiple, complex clinical studies concurrently
- Assist in establishing metrics for project progress, performance, and cost
- Represent the project or function within the department, unit or school
- May develop and/or oversee budgets
- Is Accountable for overall management and coordination of protocol related activities across countries within the region in assigned protocols
- Responsible for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
- In partnership with Clinical Operations Specialists (COS) (where applicable) responsible for the set up and maintenance of the Trial Master File (TMF) and Clinical Trial Management System (CTMS) for studies
- Work with CTT and QA to identify potential issues and implement actions to resolve them
- Where applicable oversee the work of assigned Clinical Operations Specialists(s), ensuring clear delegation /assignment of duties are documented
- Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives
- 1 – 2 year experience working with clinical trials and/or within pharmaceutical environment preferred
- Broad understanding of operations including those in related development functions Demonstrates detailed understanding of clinical protocol , intended study populations solid overall drug development
- Doctorate, Masters or Bachelor’s degree
- Previous experience working in site monitoring in phase I to III clinical trials either in CRO or a bio-pharmaceutical company
- Minimum of 3 years of clinical trial experience within the pharma/biotech industry
- Must have sponsor experience managing CROs and central vendors!