About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Purpose : To enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of Site Management & Monitoring (SMM) deliverables involving start-up, execution, and close-out of studies. The Specialist, Study Start Up and Maintenance proactively drives all start up and maintenance related activities for sites in their assigned country or countries Responsibilities : For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions. Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation. Responsible for mentoring CRAs for various aspects of work. May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager. If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner. If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update CTMS with country-level information: Country-level planning timelines, LSR assignments, etc. Primary responsibilities include but are not limited to: - collection of essential documents from sites - compiling and submitting ethics and other required local submissions - coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements - collaborating with contract manager and monitor as required to assure timely site activation - reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas - triggering clinical supply shipments - completing IP release activities and triggering IP shipment - issuing site green light letter and activating sites in IXRS - tracking all start up and maintenance related activities in Vault SSU as appropriate - maintaining local country and site intelligence database and EDLs in Vault. Qualifications Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred. Site Monitoring Experience: Minimum 3 years. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines. Demonstrated business ethics and integrity Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements. Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.