Clinical Operations Manager

Inc•Cambridge, MA

1d•Remote

About The Position

Join Beacon Therapeutics (USA) Inc. as a Full-Time Clinical Operations Manager and contribute to groundbreaking advancements in the biotech industry remotely in the USA. This fully remote position empowers you to lead clinical trials and operational initiatives that make a genuine impact on patient outcomes. You will have the opportunity to collaborate with a diverse, talented team of professionals dedicated to pushing the boundaries of innovation. At Beacon Therapeutics, we embrace a culture of accountability and continuous improvement, where your insights will be valued and encouraged. Engage in a forward-thinking environment that promotes transparency and respect, allowing you to thrive while making remarkable achievements happen. Be part of a company where your expertise can truly make a difference. As a team member, you'll be able to enjoy benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, and Employer paid STD & LTD. Take your career to the next level in a dynamic and supportive remote setting. Beacon Therapeutics (USA) Inc: Our Story If you are passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We are a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference. What's your day like? As a Clinical Operations Manager at Beacon Therapeutics (USA) Inc., you will play a pivotal role in the operational execution of clinical studies, ensuring that projects are delivered on time, within budget, and maintain the highest standards of quality. You will leverage your expertise to ensure compliance with ICH/GCP guidelines, along with all relevant regulations and standard operating procedures (SOPs) set forth by regulatory authorities. In this role, you will be responsible for coordinating cross-functional teams and streamlining processes to achieve remarkable outcomes. Your commitment to excellence and accountability will be essential in driving the success of our innovative clinical trials, ultimately contributing to advancements in patient care.

Requirements

Experience managing all aspects of clinical trial(s) from study start-up through study close-out
Direct experience managing multiple clinical trial vendors at a time
Direct experience engaging with sites to resolve issues, delays in data entry or query resolution
Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and requirements
Ability to collaborate within a team and cross functionally
Proven ability to multitask and prioritize competing priorities
Very strong verbal, written, and presentation skills

Responsibilities

operational execution of clinical studies
ensuring that projects are delivered on time, within budget, and maintain the highest standards of quality
ensure compliance with ICH/GCP guidelines, along with all relevant regulations and standard operating procedures (SOPs) set forth by regulatory authorities
coordinating cross-functional teams and streamlining processes