Project Manager Clinical Job Description

Project Manager Clinical Job Description

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Project manager clinical provides project-specific oversight of Clinical Study Associates, Clinical Trial Assistants, Clinical Research Associates and other team members;.

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:

Ensuring that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs
Evaluate and monitor study progress and workload of project management staff to ensure projects are on time and within budget
Manage overall activities to ensure compliance with internal SOPs, FDA regulations & ICH GCP guidelines
Leading the planning and communication with cross-functional teams to ensure proper execution and conduct of the trial
Serving as primary contact and resource for LCRA, CRO and vendor personnel
Supporting selection and provides oversight and management of CROs, consultants and vendors
Tracking and reporting on the progress of assigned clinical trials including budget and timelines
Preparation, oversight and review of study related documents
Working with Clinical Trial Managers, Data Management, Clinical Trial Assistant and Document Control Specialist to create and manage study related documents
Co-monitoring with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team

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:

Clinical trials in medical device
Excel
Industry and outcomes research study design
Common organization-
Research-specific and other computer application programs
ICH
Manufacturing industries
Pharmaceutical / Biotech
Project Management
Applicable policy analysis techniques

Desired experience for project manager clinical includes:

Organizing (or assists with organizing) and participates in meetings – Study Team Meetings, Investigator Meetings, Monitors’ workshops, and CRO Training
Participating in the preparation, review, updating and training of SOPs
Responsible for the planning, implementation, execution and management of clinical research studies
Participate in Protocol Writing and CRF Design
Manage all vendors, on spec, on time, on budget (including leading calls and review of invoices)
Oversee site selection

Project Manager Clinical Examples

1

Project Manager Clinical Job Description

Job Description Example
Our company is looking to fill the role of project manager clinical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for project manager clinical
  • 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
Qualifications for project manager clinical
  • 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
2

Project Manager Clinical Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of project manager clinical. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for project manager clinical
  • 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
Qualifications for project manager clinical
  • 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
3

Project Manager Clinical Job Description

Job Description Example
Our company is looking for a project manager clinical. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for project manager clinical
  • 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
Qualifications for project manager clinical
  • 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
4

Project Manager Clinical Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of project manager clinical. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for project manager clinical
  • 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
Qualifications for project manager clinical
  • 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
5

Project Manager Clinical Job Description

Job Description Example
Our company is looking to fill the role of project manager clinical. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for project manager clinical
  • 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
Qualifications for project manager clinical
  • 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!

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