Clinical Study Project Manager Jobs

Act with integrity in everything we do.

Develop superior talent and deliver expertise.

Respond with agility and provide timely results.

Embrace collaboration, diverse perspectives and ideas.

Come and work for an organization with the:

Run reports including training matrix reports, metrics for management reviews

Support management of IRB/IEC renewal compliance.

Work with management group to help achieve department goals.

Requires experience and knowledge working with computer systems (Microsoft office –

Assist in payments/tracking for patient reimbursements. Performs data entry in systems

Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.

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

Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory).

Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS).

Education Qualifications (from An Accredited College Or University)

Associate degree or with a nursing diploma with substantial experience preferred.

4 or More Years relevant experience is required with a BS preferred.

Bachelor's Degree in the Sciences preferred.

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.

Bachelor’s Degree in business administration, finance, science or related field or equivalent experience.

Central Services Specialist - ICF Management

Co-manages maintenance of the centralized Informed Consent Form mailbox.

Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.

Experience in negotiating vendor contracts/budgets.

Proven ability to effectively manage change.

Remote will be considered; however, Minnesota or central time zone will be preferred.

Familiarity with electrophysiology and/or cardiac arrhythmias is a plus.

Previous work history with CERs and EU MDRs

Previous work history in medical device or pharmaceutical research (i.e., no academia or research scientist candidate).

Previous work history in the cardiovascular space.

Minimum is BS + proven work history

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

3+ years in clinical-setting project management

Coordinate and manage implementation projects

Excellent problem solving skills and attention to detail

Improve processes across a network of clinics

Collaborate with leadership and strategic partners to improve efficiencies and quality of care

Create and maintain business analytics reports

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

• Education Requirement: BA/BS/Masters in a scientific or technological field of study.

• Minimum experience requirement: 2-3years of experience with clinical trial set-up and execution.

Job Title: Clinical operation project manager (Project Manager Scientific I (Assistant)

Software: MS office suite, any document review software experience is good to have.

• Clinical study operation experience.

Location: Upper Gwynedd, PA or WestPoint PA or Rahway, NJ

Co-manages maintenance of the centralized Informed Consent Form mailbox.

Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.

Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.

MUST CURRENTLY WORK AT A CRO/PHARMA

Reviews and validates quality and accuracy of Informed Consent Form templates.

Supports development of Informed Consent Form templates.

Management experience of CROs, Vendors and Consultants preferred

Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements

Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans

8+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment

Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators

Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required

Required knowledge, skills, and abilities

Supporting supply and inventory management, including:

Updating the inventory management system

Bachelor's Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience

Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including GCP, FDA, and IRB requirements

Collecting study data and completing data entry / case report forms in various electronic systems and on paper

Experience in project management practices.

CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

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

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

Stefanini is looking for Project Manager Business Professional/

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.

• 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.