Associate Director, Study Start Up

Location
Basking Ridge, NJ, United States
Posted
Oct 12, 2020
Ref
21655BR
Required Education
Masters Degree/MBA
Position Type
Full time
As the Associate Director, Study Start Up you will be responsible for supervising the daily Study and Site Start Up activities. You will ensure the introduction and compliance to standards regarding use of templates, data collection/capture and document management. As the AD, SSU will also be the steward of new and existing Standard Operating Procedures regarding Study and Site Start Up activities. You are a key liaison with vendors supporting study and site start up being responsible for setting expectations and managing performance of those vendors. You will also directly manage 3-5 Site Start Up team members.

In this role, a typical day might include the following:
• Providing operational input into protocol development
• Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Ensuring compliance with the clinical trial registry requirements
• Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
• Leading risk assessment and identifies risk mitigation strategies at the study level
• Leading feasibility assessment to select relevant regions and countries for the study
• Conducting site evaluation and selection
• Leading investigator meeting preparation and execution
• Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
• Managing development and implementation of patient recruitment and patient retention strategies
• Supervising data entry and query resolution and taking action on any divergence from agreed metrics
• Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Raising issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other partners and developing and implementing appropriate actions to address issues
• Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required
• Supervising study close-out activities and contributing to clinical study report writing and review
• Up to 25% Travel

This role might be for you if:
You have experience in clinical drug development process and clinical trial planning and execution practices, including IRB/ERC and Investigator Site roles and responsibilities
You have experience managing Sponsor and Site related Essential Documents, including the use of CTMS for Site Creation & management, TMF, the Master Index, Sponsor vs. Site requirements
You have shown success engaging and partnering with 3rd party service providers (CROs, Labs, etc.)
You have strong, focused project management skills with an outstanding ability to prioritize and get results across an organization and from outside vendors
You are an influencer that can tactfully push-back when necessary
You are a team play and can rally disparate groups to drive toward common goals
You have exceptional technical proficiency in MS/iOS including, but not limited to, Microsoft Project, PowerPoint/Key Note, Word/Pages,Excel/Numbers, Visio/Lucid Chart, Electronic Document Management Solutions (Veeva, NextDocs, etc.)

To be considered for this opportunity you must possess a minimum of a Bachelor's degree. You will need at least 10 years of experience in Clinical Development, ideally including direct experience in Study and Site Management. Proven and progressive people leadership capabilities are necessary for success in this role. We need someone with knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R1 and R2. Being well-versed in Clinical Trial insurance policies and procedures is also a must to be successful in this role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.