Job Summary We are seeking a highly skilled and experienced Senior Manager, Clinical Study Lead to oversee and coordinate complex clinical research projects within our organization. This pivotal role involves leading cross-functional teams to ensure the successful design, execution, and completion of clinical trials in compliance with regulatory standards and industry best practices. The ideal candidate will possess extensive knowledge of clinical development processes, regulatory requirements such as FDA regulations and ICH GCP guidelines, and demonstrate strong leadership capabilities. This position offers an opportunity to contribute significantly to advancing healthcare solutions through meticulous study management and innovative research practices. Title

• Senior Manager, Clinical Study Lead (Internal Medicine) Location
• Armonk, NY, Warren, NJ
• Hybrid; 4 days per week on site 25% Travel may be required Discover your role: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.

Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management; Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level; Leads the feasibility assessment to select relevant regions and countries for the study Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan; Monitors data entry and query resolution and acts on any deviations from agreed metrics Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight This role requires: A minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience We are seeking experience with line management as well as exceptional interpersonal and leadership skills Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization; Ability to influence and negotiate across a wide range of stakeholders Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC We are seeking extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies

Experience:

Senior Manager, Clinical Study Lead :

5 years (Preferred)

Clinical Trial Operations:

: 8 years (Preferred)

Global Clinical Trials:

2 years (Preferred)

People/Line Management:

2 years (Preferred)

Vendor/CRO Management:

2 years (Preferred) Study Start-up to

Close-out:

: 1 year (Preferred)

Budget & Timeline Management:

: 1 year (Preferred)

CTMS/eTMF/EDC:

1 year (Preferred)

GCP/ICH/FDA

Compliance:

: 1 year (Preferred)

License/Certification:

Good Clinical Practice (GCP) (Preferred) ICH-GCP (Preferred) ACRP Certification (CCRA/CCRC) (Preferred) SOCRA Certification (CCRP (Preferred)

Work Location:

In person