Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)

               At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases.  We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. 

Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment. The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical programs.  The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs.

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

•       Provides key data driven insights to study teams for study, country, and site feasibility along with start-up and enrollment forecasting.

•       Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies.

•       Prepare local and independent ethics committee submissions and responses to queries in collaboration with the cross functional team.

•       Prepare, distribute, and collect site-specific essential document packages. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up. Manage study start-up planning, and modeling.

•       Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.

•       Coordinate contract and budget negotiations between sites and internal function team and coordinate investigational product release authorization with quality assurance.

•       Implement and monitor the progress of the study initiation plan and prepare and participate in project update meetings.

•       Creates, manages, and archives central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff.

•       Serves as a point of escalation for study teams and CROs for country and site activation issues.

•       Responsible for data driven assessment of country and site scenario planning, patient enrollment assumptions and start-up data.

•       Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities.

•       Partners with CRO to ensure effective start-up processes, utilizing appropriate technologies, as required, to deliver best in class country and site activation performance.

•       Provides internal expertise in the early planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable.

·       Partners with Clinical Operations, Medical Affairs/local country offices to obtain local insights into country and site selection.

Qualifications:

• BA/BS degree in Health or Life Sciences required, advanced degree preferred. 
• A minimum 5+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
• Exceptional collaboration, communication, and interpersonal skills  
• Demonstrated ability to effectively manage external vendors & CROs
• Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets 

§  Demonstrated strong written and verbal communication skills

§  Proven mindset of proactive continuous improvement

§  Efficient independent worker with ability to focus and drive for results

§  Strong attention to detail

§  Ability to work in a fast paced-environment and to handle multiple tasks

§  Strong commitment to ethical standards

§  Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

§  Ability to travel up to 10%

§  The salary range for this position is commensurate with experience

Company offers a comprehensive benefits package including:

·       Competitive pay and stock options for all employees

·       Medical, dental, and vision coverage with 100% of premiums paid by Companyfor employees and their eligible dependents

·       Fertility and mental health programs

·       Short- and long-term disability coverage

·       Life, Travel and AD&D

·       401(k) Company Match with immediate company vest

·       Employee Stock Purchase plan

·       Generous vacation plan and paid company holiday shutdowns

·       Various mental, financial, and proactive physical health programs covered by Company