Manager, Trial Delivery Manager

Janssen Research & Development

About The Position

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 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.

Requirements

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years in Pharmeceutical, 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 muti-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.

Nice To Haves

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

Responsibilities

Create and update 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).
Support development of program-level compound training, collaborating with Clinical / CTL&D Medical writing.
Provide input into trial level operational strategies.
Resolve trial-related issues and mitigate trial-related risks.
Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
Mentor & support onboarding of new team members, particularly those in Trial Management.
Foster employee engagement, inclusion, and Credo Behaviors.