Senior Manager Clinical Study Lead (Clinical Experimental Sciences)

About the role

The Senior Clinical Study Lead (CSL) Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out. Additionally, there are responsibilities for initiation, oversight and completion of CES Ops continuous improvement and Strategic Imperatives workstreams.

Responsibilities

• Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Provides operational input into research plan and/or study protocol development
• Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol.
• Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
• Provides input into baseline timeline development and management
• Provides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market Value
• Ensures accurate budget management and scope changes for internal and external studies
• 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
• Oversees the execution of the clinical study against planned timelines, deliverables and budget
• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• Manages and oversees study close-out activities
• Ensures End of Study Summary is delivered and properly archived
• Facilitates and contributes to study level lessons learned
• Sets up and manages tasks for Clinical Study Management staff and supports their deliverables
• Recommends and participates in cross-functional and departmental process improvement initiatives
• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and procedures
• Works with Therapeutic Focus Area groups within Basic Research/Discovery
• Works closely with clinical site staff, predominantly at academic institutions
• Expected to maintain higher volume and/or greater complexity studies
• Expected to communicate learnings, best practices and relevant information to other study leads at all levels, ensures consistency and internal alignment across staff
• May be 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

Requirements

• A minimum of a Bachelor's degree and 8+ years of relevant clinical experience is required.

Qualifications

• Minimum of a Bachelor's degree and 8+ years of relevant clinical experience is required.

Skills

• Strong project management and organizational skills
• Excellent communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Experience working with clinical trial management systems (CTMS)
• Knowledge of Good Clinical Practices (GCP) and regulatory requirements
• Ability to work independently and as part of a team
• Strong problem-solving and decision-making skills

Benefits

• Comprehensive health and wellness programs
• Flexible work arrangements
• Retirement savings plans
• Professional development opportunities

Pay

$150,500.00 - $245,500.00 annually

Schedule

Full-time