Senior Clinical Research Associate
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin's Development Sciences Operations (DSO) group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives.
The Senior CRA role leads all day-to-day Clinical Operations (CLO) functional activities associated with the execution of one or more clinical trials. Responsible for oversight of CLO study team, the Clinical Research Organizations (CROs), and third party vendors associated with the study. Capable of overseeing and executing on all delegated tasks associated with clinical trial execution. PRIMARY RESPONSIBILITIES:
Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin SOPs, ICH and FDA and other Health Authorities [HAs]) Oversee study feasibility assessment activities (if applicable) Ensure timely development and finalization of key study plans and manuals as per the Study Team charter Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead Provide CLO study activity timeline and budget inputs to overall Study Team timeline and budget Lead cross-functional effort to define enrollment strategy and plan for the study Participate in strategic study planning meetings (such as DMC, advisory board, steering committee) Provide study status updates to the Study Team and Study Team Lead
• In collaboration with appropriate teams, oversee and approve vendor evaluation and selection Oversee day-to-day management of CRO and vendors' contracted activities as per oversight plans Work with Business Operations group to ensure final payments to vendors at study closure
Lead site identification, qualification, selection and activation activities for the study, including activities such as site and staff training, site budgets, site ICF and coordination of site investigator contracts with Clinical Contract & Grants Plan and deliver IM in collaboration with other key stakeholders
Ensure adherence to study enrollment strategy and plan Ensure adherence to monitoring plan Ensure adherence to monitoring oversight SOP Ensure timely site payments.
Cross Functional Activities:
Act as CLO contact and represent CLO at the intenal study team meetings Prepare and communicate study updates via study dasboards Manage any protocol deviations, as necessary Provide forecasts for clinical supply, ancilliary supplies. Contribute to departmental initiatives as needed.
Required Skills / Experience:
Ability to communicate with excellent interpersonal, presentation, written, verbal, analytical, organizational skills. Must be proficient in on-going project management. Possess a strong commitment to quality and accuracy as a self-starter and a team-player. 5 years of pharmaceutical industry experience in pharma or biotech environment
Previous experience leading a cross-functional team.
Bachelors degree, MS, preferably in Life Sciences ~BIO #LI-KO1