Pharmaceutical Research Associates, Inc.
US-Remote | US-PA-Blue BellOverview Location - Blue Bell, PA or Remote US
Achieves successful delivery of operational activities (site management, clinical monitoring, and/or data review) by meeting internal and external client requirements. Oversees the management of physician sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines (such as ISPE GPP) and applicable regulations, as well as SOPs. Contributes to Business Development Activities by participating in proposals and bid defenses as required. Along with the OSM (Operational Study Manager) role on a project, may function in a PM role with mentoring and supervision. Responsibilities Key Responsibilities:
- Manages all study site related activities in a project with a low to medium complexity. Low to medium complexity is defined through several criteria including, but not limited to, the number of patients/sites/countries/regions, duration of start-up and patient enrollment/registration, and study design.
- Acts as regional OSM in an international/global project in support of a global OSM.
- Project Planning, Set Up and Conduct, Communication and Reporting, Training and Oversight
- Plans for all activities in a project related to investigational sites and generates the related planning documents depending on the scope of work (including but not limited to Study Start-up Plan and Site Management Plan).
- Serves as primary liaison for the client for all site related issues, including but not limited to site management and applicable clinical monitoring issues, escalating as required.
- Addresses and resolves all internal and external issues related to site management for client research projects managed by PRA LPS.
- Provides data as required for clinical operations performance metrics and project status metrics.
- Assists with design and set-up of various analytic tools/dashboards to assess study status and site performance, and to aid in site management and prioritization of related tasks.
- Defines and provides project-specific training for the site management and regional monitoring team and ensures relevant training is completed before the team members start on a specified task.
- Creates and maintains applicable project documents, templates and tools, including but not limited to training material (e.g. Site Initiation Presentation, Investigator Site Binder, Site Management Contact Checklists/Reports, Annotated Monitoring Reports, and Essential Document Review Checklists.)
- Leads the site management and regional monitoring team on a project, providing oversight and mentoring as required.
- Manages site recruitment at the beginning of the study and supervises the selection of the sites to be utilized for the study.
- Develops the regulatory submission strategy and supervises the submissions in the different countries involved (for multi-country studies).
- Participates in Investigator Meetings and/or physician and site training sessions conducted via telephone and webcast conferences.
- Supervises patient enrollment/registration, study data review, and query resolution efforts.
- Plans and/or coordinates the on-site visits as required per study.
- Reviews and approves monitoring visit reports and ensures tracking and resolution of ongoing site issues.
- Liaises with Site Management Associates regarding site management, data review, and query resolution issues providing guidance and suggestions for resolution.
- Liaises with Clinical Research Associates regarding all site monitoring issues providing guidance and suggestions for issue resolution.
- Interfaces with other project team members outside of clinical/site management to ensure that study milestones and outcomes are achieved.
- Manages the operational budget and identifies out of scope tasks from the operational team and escalates as required.
- Requests resources and forecasts resource needs for the operational team (SMAs, CRAs, Local In-House CRAs, CSS, etc.)
- Operationalizes and executes long-term site and patient retention plans, prescriber recruitment plans, and direct
- To patient follow-up plans developed in conjunction with project management and scientific affairs director(s), if applicable.
- Collaborates with Clinical Informatics in achieving successful delivery of data management deliverables, meeting internal and external client needs:
- provides day-to-day oversight of the clinical data review process during study conduct
- Reviews and provides input on data management plans for content and structure
- Helps ensure that applicable quality control steps are properly planned and completed
- May assume other data management activities as assigned
- Manages relationships with Key Opinion Leaders and Steering Committee members to ensure study related communications are consistent and effective.
- May participate in corporate initiatives, process improvements and PRA (LPS) working groups to ensure the continual success of PRA.
- Contributes to Business Development activities, participating in proposals and bid defenses as needed.
- Ability to understand the big picture - the scientific goal of their project, how the study design relates to that, why the client is doing the research, what the regulatory requirements will be for a particular study (in late phase, this does vary more than in PR), independent problem solving to make sure timelines are met, assessing risk at the project and also site level, prioritization to meet client needs and deliverables. The OSM needs to also understand how the smaller site-level tasks that the SMAs are doing fit into this big picture.
- The OSM role is client-facing so we need someone with solid experience who will be able to handle demanding clients. We need the clients to feel like they have confidence that they're in good and experienced hands, someone who has experience in a variety of therapeutic areas/study designs in late phase is ideal.
- Strong leadership skills as they lead the SMA team - approachable enough to encourage them to escalate issues and be a mentor but, again, strong enough to keep them on track and accountable.
- Good, polished presentation skills (delivering a presentation is part of the interview) - they will need to participate in bid defense meetings and regularly present progress updates in client meetings and they can't get rattled by tough questions.
- Data management experience is also an important asset for OSMs to have. This is an important element of the role and really, what our clients are looking for in the end is clean data of high quality.
- 3+ years clinical research experience including site monitoring and management of study sites from start-up through close-out
- Experience leading professional staff in a clinical research environment
- Knowledge of current post marketing regulatory environment
- Proven skills with electronic data capture software
- Substantial experience using computerized information systems, electronic mail, word processing, and electronic spreadsheets
- Read, write and speak fluent English
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required
- Previous experience working on large multi-country studies in an OSM or similar role
- 2-3+ years late phase experience
- Previous experience coordinating a group of OSMs (or equivalent) on global studies
- Previous project management experience
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.