Manager, Trial Delivery Management

Position Summary

The Manager, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The Manager TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

Responsibilities

• Creating and updating critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
• Vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
• Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
• Supporting development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.
• Providing input into trial level operational strategies.
• Resolve trial-related issues and mitigate trial-related risks.
• Participating in process improvement activities at a trial, compound & cross-DU level, as needed.
• Providing support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentoring & supporting onboarding of new team members, particularly those in Trial Management.
• Fostering employee engagement, inclusion, and Credo Behaviors.

Principal Relationships

Internal: Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement

Education and Experience Requirements

• BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries
• Experience in and knowledge of the pharmaceutical development process
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial
• 2-3 years' experience leading multiple aspects of a global clinical trial
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness
• Experience of leading without authority and in multi-functional matrixed and global environments
• Excellent decision-making, analytical and strong financial management skills are essential to this position
• Operate and execute with limited supervision
• Experience mentoring/coaching others
• Strong project planning/management, communication and presentation skills are required

Required Skills

• Mentor Coaching
• Trial Management
• Vendor Management

Preferred Skills

• Analytical Reasoning
• Budgeting
• Clinical Trial Management Systems (CTMS)
• Clinical Trials
• Compliance Management
• Contract Management
• Execution Focus
• Fact-Based Decision Making
• Laboratory Operations
• Mentorship
• Process Improvements
• Project Integration Management
• Research and Development
• Research Ethics
• Standard Operating Procedure (SOP)
• Technical Credibility

Pay

The anticipated base pay range for this position is $117,000.00 – $201,250.00.

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k))
• Long-term incentive program
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year