Pra International Work Values

Daily Duties at Pra International:

ACCOUNTABILITIES-For Start-up Services Clinical Project Management • Creates and maintains clinical project documents, including but not limited to Study Start-up Plan, Informed Consent Checklist, Clinical Site Status Reports, Project Essential Document Checklist, Investigational Product Release Checklist and CTMS activity templates • Ensures consistent implementation of Start-up Methodology • Plans, oversees, and conducts meetings with the start-up team to ensure compliance with established practices and SOPs • Serves as primary liaison and primary point of escalation for start-up issues, interacting with clients, vendors and other PRA functional areas • Works with the PM to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the start-up phase of the study • Provides data as required for start-up performance metrics and project status metrics applying and drawing conclusions between project activities/deliverables and project metrics and initiating measure to improve metrics • Identifies out-of-scope tasks from start-up team and escalates as required • Provides Time Entry Guidelines to the In House CRAs, Contracts Associates and Regulatory Affairs Associates in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager • Forecasts units and hours and generic resources for In-house CRAs, Contract Associates and Regulatory Affairs activities; determines worked units and hours analyzing forecasted and worked activities to ensure adherence to contract and budget • Participates in client meetings, assisting with presentations as required • Contributes to Business Development activities participating in proposals and bid defenses as needed • Attends Project Status Review (PSR) as needed to provide Start-up summary Client Deliverables Management • Oversees start-up activities including site selection and regulatory document collection • Reviews site activation forecasts and ensures critical path activities are on target • Provides oversight of Ministry of Health submissions for those countries that submit directly to the Ministry of Health • Liaises with Regulatory Affairs Associate to ensure Ministry of Health submissions for non-direct countries are on target • Provides oversight of Local/Central Ethics Committee submission tracking • Provides training to assigned IHCRA project team to ensure essential document quality • Oversees Investigational Product Release Process • Ensures the delivery of appropriate study specific training • Conducts document review as needed • Oversees document versioning process – ie, Informed Consents, Questionnaires, etc. • Directs the transition of study activities to the maintenance IHCRA team as start-up activities are completed Clinical Team Management • Liaises with Clinical Operations Managers to resolve resource and performance issues • Interfaces with other project team members as required until study start-up outcomes are achieved • Leads the IHCRA team on a project, providing training and mentoring as required. • Actively promotes positive team dynamics through effective listening and communication including interactive participation in team meetings, sharing of information and proactive problem identification/solving ACCOUNTABILITIES- For Clinical Monitoring Services Clinical Project Management • Creates and maintains clinical project documents including, but not limited to Clinical Management Plans, Monitoring Guidelines, Site Operations Manuals and Monitoring Visit Letter templates, other CTMS activity templates, Monitoring visit presentations/scripts, Patient Recruitment Plans • Coordinates the day to day activities for the monitoring of a clinical study including document flow and communication to/from sites and vendors • Serves as primary liaison for clinical monitoring issues, in iteracting with clients, vendors and other PRA functional areas, escalating as required • Provides data as required for clinical operations performance metrics and project status metrics, applying and drawing conclusions between project activities/deliverables and project metrics and initiating measure to improve metrics • Provides Time Entry Guidelines to the CRAs and In House CRAs in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager • Identifies out-of-scope tasks from clinical monitoring team and escalates as required • Forecasts units and hours and generic resources for In-House CRA and CRA activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget • Analyzes data to determine impacts to clinical activities; identifies issues and risks, identifying possible solutions to resolve the issues and mitigate the risks • Works with the Project Manager to build and foster the client relationship • Participates in Investigator meetings, assisting with presentations as required • Contributes to Business Development activities participating in proposals and bid defenses as needed Clinical Deliverables Management • Takes ownership for clinical deliverables to do what is needed to make In House CRAs, CRAs and outputs successful and provide quality and on-time delivery • Evaluates and confirms the selection of clinical investigative sites • Provides useful tools to CRAs for conducting monitoring tasks • Reviews and approves monitoring reports and ensures tracking of ongoing site issues • Supervises Investigational Product accountability, subject screening/enrollment, Case Report Form retrieval, and query distribution to/retrieval from investigator sites • Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines • Ensures the delivery of appropriate study specific and therapeutic training to the clinical team Clinical Team Management • Builds and leads a cohesive clinical monitoring team on a project, providing coaching and mentoring on project specific clinical tasks, delegating tasks as required. For large multi-national studies this may be a team of Clinical Team Managers • Communicates consistently with the clinical team providing project objectives and expectations, status updates, celebrating successes and highlighting issues; ensures a communication plan is in place to co-ordinate communication between functional team members, CRAs, In House CRAs, other CTMs and the client • Liaises with CRAs regarding site monitoring issues providing recommendations and suggestions for issue resolution • Liaises with Clinical Operations Managers to resolve resource and performance issues • Interfaces with other project team members as required to ensure clinical monitoring outcomes are achieved, particularly the Lead Data Manager • Plans, oversees and conducts initial and ongoing training to the study team on study specifics including therapeutic area training, protocol specific training, safety monitoring/reporting requirements, drug management and data management • Contributes to the clinical monitoring team on a project, providing training and mentoring as required • Actively promotes positive team dynamics through effective listening and communication including interactive participation in team meetings, sharing of information and proactive problem identification/solving • Conducts co-monitoring visits as needed • Responsible for evaluating and confirming approval for selection of sites

What they like about Pra International:

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

Tags

Leader, Instructor, Mentor, Training Specialist, Manager, Team Oriented

Skills

P&L responsibilities, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Pra International: