Clinical Operation Project Manager Jobs

Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities

Knowledge of global clinical trial management in CRO outsourced environment

Lead and manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge

Lead the development of contingency/risk management plans and associated mitigation strategies

Manage and provide mentorship for junior clinical operations team members

Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure

Operate independently across business functions in support of VP Clinical, data management, engineering, and regulatory teams.

Medical Benefits – We offer a range of policies through TriNet

Manage/coordinate marketing studies across internal functions including Clinical, Research and Product Development.

Monitor studies in accordance with regulatory requirements, Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and the Good Manufacturing Practices (GMPs).

Advanced understanding of imaging modalities (MR, CT, etc.) to help align clinical and engineering validation requirements to accelerate regulatory clearances worldwide.

Statistical analysis of development data; knowledge of diagnostic analysis techniques.

Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus.

Project Management Certification (PMP) is a plus

Reviews study metrics for performance and quality with the team and management

Prepares high-quality reports (financial, project, etc.) for management on program status and issues

Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.

Responsible for leading clinical trial team meetings. May manage the GDT meeting and perform all required cross-functional follow-up

Exhibit independent problem solving and proven project management skills

Collaborates with Operational teams when applicable to ensure effective and efficient study implementation and management as it relates to operational processes.

Assist with the preparation and processing of Serious Adverse Event (SAE) reports as required to meet study-specific requirements.

Extensive clinical research knowledge and understanding of clinical trial methodology

Show strong interpersonal, analytical, and organizational skills

Demonstrate word processing, spreadsheet, and PowerPoint skills

Degree in Business, Science or Engineering or equivalent related experience with completion of an accredited management course.

Knowledge / Skills / Abilities

Education / Experience / Background

Demonstrated leadership ability and ability to manage resources (personnel, equipment, materials, facilities, funds and reputation).

Demonstrated knowledge of budget preparation and cost control and have the ability to forecast budget, staffing and equipment needs.

Demonstrated effective communication, presentation and interpersonal skills in order to interface with and motivate all levels of personnel.

Experience in corporate strategy, product/platform strategy, strategic finance, or similar, and have a foundational understanding of platform and SaaS business models

1 Management consulting background (Deloitte, BCG, McKinsey)

Demonstrated experience in contributing to business case development/strategic recommendations from end-to-end

Experience supporting qualitative and quantitative customer or market research

Excellent verbal & written communications skills

Industry experience in SaaS or platform business models

Determine clinical education training needs and schedule the Clinical Services staff - 40%

Process Registrations for upcoming the Education Events – 40%

Partner with Zone Manager and Customer Relationship Manager and Service Teams to coordinate and manage customer training for ongoing training needs

Determine clinical education training needs and schedule the Clinical Services staff to meet department financial, operational and customer satisfaction targets

Educate external customers about features and benefits of the Clinical Services Portfolio to improve related sales.

Monitor increase/decrease in demand for education products and escalate as appropriate.

Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.

May be assigned to oversight and management of cross study/department initiatives and/or vendors.

Will assist in oversight and management of CROs, consultants and vendors.

Ensures assigned studies adhere to all applicable regulations and requirements.

Experience in phase I-III clinical studies. Global experience a plus.

Ability to work effectively in a team setting, remote teams, and fast paced environment.

Gathering input from project teams and senior management

gathering input from project teams and senior management

Evaluating current state of the business and capabilities

Determining testing requirements, attributes, and selection

Collecting and determining requirements of projects and innovation opportunities

Gaining buy-in on deliverable requirements

• Experience in project management practices

• Possesses working knowledge of research objectives, protocol design, and data collection standards

• Experience with clinical operations systems including EDC, CTMS, and eTMF

3 years project management experience

Responsible for the management and overall coordination, status reporting and stability of a variety of enterprise-wide projects.

Technical and/or R&D background with CMC experience strongly preferred

As a Project Manager you will:

Provides facilitation of meeting logistics, including scheduling, agendas and minutes.

May work closely with internal departments and outside vendors to ensure project completion.

3-5 years of clinical operations experience with at least two years of clinical project management experience.

Clinical Research Certification (SOCRA or ACRP) and/or project management certification (PMP) is desired.

Required Knowledge, Skills and Abilities:

Experience at a sponsor or CRO within Medical Devices is strongly preferred.

Proficient in Microsoft Office Suite and working knowledge of eTMF, CTMS, and EDC systems.

Experience developing and writing clinical study protocols and reports is a plus.

·Proactively monitor and report trial progress, performance and financial metrics on an ongoing basis to management team

ØOperational expertise in risk management and contingency planning.

·Provide supervision to the clinical operations managers

ØStrong leadership and influencing skills across geographies and culture differences.

ØProven ability to manage budgets and resource.

ØExperience in international CROs preferred.

Advanced skills and through knowledge in regard to all clinical operations and site management activities

Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality

Project Management – Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards.

Study Management Tools – Ensures that study teams and clinical sites have the appropriate study management tools to execute the study.

Trial Master File - Ensures that the study regulatory files are collected and inventoried and filed as per SOP requirements.

Ancillary Supplies – Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations.

Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management

Solid understanding of clinical operations and study management processes, along with experience in various phases of development and therapy areas

Demonstrated Project Management skills (e.g., leading delivery team)

Keeps own knowledge of best practices and new relevant developments up to date.

Excellent knowledge of spoken and written English

Strong communication skills with the ability to build positive relationships, including vendor leadership skills