Overview
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function
R&D Operations
Job Sub Function
Clinical Trial Project Management
Job Category
Professional
All Job Posting Locations
Beerse, Antwerp, Belgium, Berlin, Germany, Issy-les-Moulineaux, France, Leiden, Netherlands, Lisbon, Portugal, Madrid, Spain, Milano, Italy, Stockholm, Stockholm, Sweden, Warsaw, Masovian, Poland
Job Description
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 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.
Principal 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.
Additional Responsibilities May Include
* 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.
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. External: Vendors
Education And Experience Requirements
Required Minimum Education: BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)).
Required Years Of Related Experience Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
Required Knowledge, Skills And Abilities
* 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.
Education And Skills
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
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