仕事内容
A Typical Day:
As a Senior Clinical Study Lead, you will:
Lead cross-functional study teams to ensure clinical study delivery.
Provide operational input into protocol development and oversee study-specific documentation.
Manage clinical trial systems such as CTMS and TMF, ensuring compliance with registry requirements.
Identify outsourcing needs, engage vendors, and oversee contracting and management.
Develop and manage study budgets and timelines while mitigating risks.
Oversee site evaluation, selection, and activation, including investigator meetings.
Monitor patient recruitment strategies and ensure data quality.
Supervise study close-out activities, including database lock and reconciliation of vendor contracts.
Contribute to clinical study report writing and process improvement initiatives.
This Role May Be For You If:
You thrive in leadership roles, with the ability to build and guide productive study teams.
You excel in managing complex clinical trials and balancing direct leadership with oversight responsibilities.
You have advanced technical proficiency in trial management systems and MS applications such as Excel, PowerPoint, and Word.
You possess exceptional communication skills, both written and verbal, and are adept at influencing and negotiating across diverse stakeholders.
You are proactive, self-disciplined, and skilled at prioritizing tasks to meet deadlines effectively.
You demonstrate expertise in global clinical trial operations and regulatory guidelines.
You are passionate about driving innovation and continuous improvement in clinical study execution.
To Be Considered:
Candidates must possess a Bachelor’s degree and have at least 8 years of relevant industry experience. Advanced project management skills, cross-functional leadership, and knowledge of ICH/GCP guidelines are essential. Preferred qualifications include line management experience and proficiency in vendor management.
This is your opportunity to lead groundbreaking clinical trials and contribute to the advancement of global healthcare. Join us and be part of a team dedicated to excellence and innovation in clinical trial management.
本ポジションにご興味をお持ちいただけましたでしょうか。みなさまのご応募を心よりお待ち申し上げております。我々の企業理念であるRegeneron Wayを共に歩む、その第一歩を踏み出しましょう。当社では、多様性を大切にする企業文化に基づき、幅広い内容の福利厚生をご用意しております(内容は地域によって異なります)。米国の場合、ヘルス&ウェルネスプログラム(医療保険、歯科治療や眼科治療に関する保険、生命保険および身体障がいに関する保険など)、フィットネスセンター、確定拠出年金(401k)、家族支援制度、株式報酬、年次ボーナス、有給休暇、および特別有給休暇制度(例:育児休暇、軍務休職)などがあり、対象となる社員の方であれば、すべての職位においてご利用いただけます。当社の、米国における福利厚生の詳細に関しましては、https://careers.regeneron.com/en/working-at-regeneron/total-rewards/をご参照ください。その他の国における福利厚生に関しましては、採用担当者までお問い合わせください。
最高の仕事を通じて最もすばらしい成功を手にするためには、社員が一丸となって働くことこそ重要である、という信念に則り、当社では多くの職種において、オフィス勤務を必須とさせていただいております。オフィス勤務に関する当社のポリシー、および勤務内容や勤務地に関するみなさまお一人おひとりの個別の条件につきましては、採用担当者にお問い合わせください。
