Senior Clinical Research Associate

Abbvie (Tokyo, 日本) フォロー 1日前

今すぐ適用する

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

求人内容

Objectives :
• 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 SMM deliverables involving startup, execution, and
closeout of studies.

Responsibilities :
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• 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. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
• 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 coaching and mentoring CRAs and providing input into their development.
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 Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
• If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
• If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors.

資格

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.
• Experience as a team leader is preferred.
• Experience as a CRA or CRA leader in oncology therapeutic area is preferred.
• English: intermediate to business level
• Japanese: business level to native level

その他の情報

AbbVieは、誠実な事業運営、イノベーション推進、人々の生活の変革、地域社会への貢献、そしてダイバーシティ＆インクルージョンの促進などに尽力しています。AbbVieの採用方針は、人種や肌の色、宗教、国籍、年齢、性別（妊娠を含む）、身体的・精神的障がい、病気、遺伝情報、性同一性または表現、性的指向、婚姻状況、退役軍人やその他法的に保護されたグループに属するかどうか等に関わらず、高い能力を持つ優秀人財を従業員や候補者として差別することなく雇用することです。　