Clinical Study Risk Manager
- Contract Type
Location: Raleigh, NC
TalentSource Life Sciences is currently searching for an experienced Clinical Study Risk Manager to join one of our partner companies - a leading international biopharma in Raleigh, NC.
This is a permanent role with TalentSource and the successful candidate will be working on studies dedicated to one client. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your TalentSource Line Manager.
The Clinical Study Risk Manager will develop and execute the Key Risk Indicator Monitoring plan to identify triage risks then determine and track recommended migratory actions through completion. In addition, the Clinical Study Risk Manager will support the development of a robust risk management plan by contributing to and driving the identification of critical data to optimize the use of data surveillance cross-functional activities to monitor key study risks.
- Pro-actively identify key risks, critical data and critical processes to contribute to the development of the cross-functional risk mitigation plan based upon protocol summary, protocol and other pertinent key documents.
- Identify study CRF data collection needs not addressed by the biopharma's standards and pro-actively notify and engage the data standards team as appropriate.
- Critically review and approve or provide directed feedback: 1) critical variables (in consultation with Global Statistical Sciences), 2) edit check specifications (ensuring critical risk assigned in the cross-functional risk mitigation plan are addressed).
- Contribute to the study definition of important protocol deviations and proactively advocate for them to be data derived.
- Develop Key Risk Indicator Monitoring Plan for review and approval by study team based upon study risk assessment.
- Execute Key Risk Indicator review in accordance with Key Risk Indicator Monitoring Plan and document review and any associated risk/issues and action items.
- Analyze, manage and report status of trends and backlog for Key Risk Indicators and associated action items. Proactively communicate and escalate as appropriate.
- Lead change agent within study teams to help embed risk-based monitoring within the organization. Support the organization's philosophy to work in cross-functional global teams.
- Participate in and actively contribute to meetings to discuss study, site and patient level trends, and identify potential risks and issues.
- Contribute to the development and improvement of relevant processes, tools, Key Risk Indicator analytics and training for centralized risk monitoring.
- Such other responsibilities and projects that the Company may assign.
Experience, Skills, Knowledge
- Bachelor's degree in sciences, Master's degree preferable
- Significant previous experience in a similar role, preferably in clinical study management, site monitoring, data management, and/or biostatistics.
- Demonstrated experience analysing and evaluating data to make decisions and determining appropriate responsive actions.
- Working knowledge of medical terminology, government regulations and Good Clinical Practice.
- Knowledge of regulations and industry guidance documents governing quality by design and risk-based monitoring.
- Prior, small scale, experience leading/participating in initiatives involving process and/or procedure development and leading change.
- Demonstrated experience communicating with all levels of personnel and participating in collaborative work teams (locally and globally).
- Demonstrated experience managing multiple tasks concurrently and responding rapidly to changing priorities with aggressive timelines.
- Strong analytical skills and attention to detail
- Ability to challenge and influence study team colleagues and other stakeholders to help embed risk-based monitoring within the organization
- Ability to adapt to change, work in a rapidly changing environment and manage uncertainty.
- Ability to effectively organize ideas for logical presentation and acceptance.
- Project management skills.
- Ability to set personal objectives and determine appropriate courses of action.
- Ability to adapt to working in a multicultural environment with teams located globally.
- Ability to work with limited close supervision.
- Analytical in nature and able to understand the rationale and interpret the content of clinical protocols and associated risk assessments for the purposes of developing and executing a fit for purpose Key Risk Indicator Monitoring Plan.
- Demonstrated communication, interpersonal, organizational and problem solving skills
- Computer proficiency
- High levels of initiative, drive and commitment
- Proficiency in English, written and verbal
- Ability to assess and prioritize the clinical implications of data signals/trends and determine appropriate migratory actions
- Ability to gather facts and data to evaluate processes and situations in an orderly and rational manner, ask questions and identify missing information
- Ability to quickly identify, analyse and solve problems, communicate any trends in the data appropriately to the applicable/responsible stakeholders, prior to risks/issues becoming critical.
Why TalentSource Life Sciences/CROMSOURCE?
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Keywords: Clinical Study Risk Manager, Risk Manager, Risk Management, Risk Based Monitoring, CRO, Biopharma, Pharma, Biopharmaceutical, Outsourced, Permanent
Clinical Study Manager, Global Study Manager, Study Manager