PURPOSE AND SCOPE:
The Clinical Project Manager is a high impact, leadership role responsible for key elements of program execution within Frenova's Team. The CPM role requires a talented individual with proven expertise in leading cross functional teams and driving the study planning, startup and execution. The CPM in partnership with the Frenova team members, Sponsor, CRO staff, vendors and Study sites, will drive study management and ensure clear and timely communication of project strategy implementation plans and program progress. The CPM will work to ensure the cross functional teams operate effectively with Positive team dynamics driving study progress. The CPM is expected to be knowledgeable about the overall indication, study product and over all development in order to be strategic in planning, program progress, oversight, communication and site management, delivering high quality project management expertise, leadership and other high value services that support the team and improve the probability of study success.
The CPM acts as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget and with the highest level of quality possible. The CPM monitors and tracks the progress of clinical study activity at research sites ensuring compliance with all local, state and federal regulatory requirements.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsible for the routine cross-functional operations of the assigned study or studies for one or more clients.
Ensures the Trial Master File documents for assigned sites is maintained and ready for inspection.
Provides support with regulatory agency and sponsor inspections/audits.
Provides leadership and assistance to Project Assistant/Associate level staff with complex tasks that require a high level of understanding of functions.
Motivates cross-functional project teams, facilitating the team's ability to fulfill their responsibilities in accordance with project contracts, contract amendments, applicable regulatory, ICH GCP and Standard Operating Procedure (SOP) requirements and company policies and procedures.
Functions as a liaison between Sponsor/CRO and the project team for project issues, including initiating, planning, executing, overseeing, and closing out of assigned studies.
Coordinates and manages day to day operational aspects of multiple concurrent projects with competing timelines independently and as defined in each project's scope.
Develops and maintains project metrics, timelines, budgets and deliverables including project plans, trackers and tools for assigned projects.
Utilizes defined guidelines and checklists, supports the coordination, oversight and tracking of clinical research studies, and ensures clinical activity receives appropriate regulatory approvals and is conducted in compliance with the protocol and OHRP, ICH/GCP guidelines, FDA regulations, and all applicable regulatory requirements.
Utilizes a clinical trials management system (CTMS) effectively and accurately, according to SOPs and Working Practice Guidelines. Using the CTMS as the source system for both operational and financial management across all clinical trials.
Consults with operations teams on the basic study outline build in the CTMS system.
Oversees routing, tracking and collation of site feasibility questionnaires, as required.
Works with team to identify potential research sites for study sponsors
Prioritizes study start up activities, collects appropriate documentation, prepares submissions to Independent Review Boards(IRBs) and submits to the board on behalf of the site, negotiates Clinical Trial Agreement, monitors patient recruitment.
Oversees preparation, routing tracking of Confidentiality Disclosure Agreements (CDA), and Clinical Trial Agreements (CTA) with input from legal.
Reviews overhead fees and lost revenue as calculated/stated in the CTA, and maintains records of revenue received to ensure funds are allocated to the appropriate dialysis facility.
Oversees and supports the Project Assistants and Project Associates activity with respect to regulatory document collection and Trial Master File maintenance for applicable studies, and directly assist with such activities as needed.
Assists with initial investigator and site recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs.
When Frenova Monitoring is scoped for a study the CPM supports the CRA Manager by tracking monitoring reports for receipt, review and sign off on per specified timelines as defined within applicable SOPs.
Negotiates and tracks individual site study budgets, with input from Business Operations.
Tracks and reports on team adherence to budget and contract terms.
Reviews and reconciles study activity via Electronic Medical Records (EMR), Electronic Data Capture (EDC), Electronic CRF (eCRF), and/or CTMS as required to ensure accurate and timely set-up and maintenance of data.
Works with Business Operations to ensure project invoices and site/vendor payments are accurate, timely, and in alignment with applicable agreements and Statement of Work (SOW).
Evaluates site activation and site enrollment against projections throughout the course of the study, escalating issues as required and ensuring sponsor/CRO/internal customer/external customer expectations and appropriate regulations are being met.
Works with sponsor/CRO to support patient retention strategies.
Reviews and monitors assigned studies for billing and cost reporting compliance.
Calculates and submits documentation for physician payment and facility reimbursement for lost revenue and overhead fees
Manages and oversees team study close-out activities.
Assists sponsor/CRO with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues.
Develops and maintain data collection/study tracking tools and reports and metrics.
Oversees the timely execution of key study milestones, ensuring that sponsor/CRO expectations are met and in alignment with applicable agreements and SOW.
Creates and distributes study specific newsletters as required.
Collates and communicates end of study site performance metrics, issues and lessons teamed to appropriate parties.
Escalates issues and critical project matters in a timely manner to the appropriate team, sponsor and CRO contacts
Ensures project documentation is complete, current, stored appropriately and audit-ready
Participates in study specific training as required by sponsor/CRO
Becomes an expert on each assigned protocol/study, consulting with the sponsor as needed for clarification.
Acts as a resource and leader to CRAs, investigators, site staff, and others regarding protocol and study-specific questions.
Develops and maintains close working relationship with sponsor/CRO's study management team(s) to ensure client satisfaction and operational excellence.
Establishes a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters.
Provides outstanding customer service to internal and external contacts.
Takes initiative and action to respond, resolve and follow up regarding customer service issues with customers, sites and sponsors in a timely manner.
Attends face to face investigator meetings to present training as needed.
Performs tasks according to SOPs and Working Practice Guidelines as specified in the SOW.
Assists in the development of departmental Standard Operating Procedures.
Assists with various projects as assigned by direct supervisor.
Other duties as assigned
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Day to day work includes desk and computer work.
Requires travel to investigator, Sponsor, Vendor meetings and investigative sites as required. Approximately 20% travel is required for this position
There may be exposure to infectious agents.
Bachelor's Degree required; Advanced Degree desirable, if no Bachelor's degree, 10 or more years of management experience in the Pharma/Biotech/Device industry with a proven track record of leadership and study team oversight and a research professional certification.
Bachelor's Degree required preferably in life science, nursing or health care field
Research professional certification (ACRP, SOCRA, RAPS, etc.) preferable (required if no Bachelor's Degree).
EXPERIENCE AND REQUIRED SKILLS:
5 8 years' related experience; or a Master's degree with 3 years' experience or equivalent directly related work experience.
Clinical trials support or pharmaceutical industry experience required.
Documented training and knowledge of FDA and GCP/ICH guidelines and drug and device regulations relevant to clinical trials.
Excellent professional writing and verbal communication skills.
Demonstrated leadership skills, organizational skills, and attention to detail.
Self-motivated, adaptable to a dynamic environment, flexible, open to change, and willing to learn new skills when required.
Able to collaborate effectively with the study team, cross-functional team members, and external partners.
Ability to work independently, either individually or within a team structure, with minimal direction.
Strong computer skills, with proficiency in Microsoft Office applications.
Previous use of a clinical trials management system is required.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care