Job Function: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category:Professional
All Job Posting Locations:Remote (US)
Job Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Remote work options may be considered on a case-by-case basis and if approved by the Company.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.We are searching for the best talent for Manager, Trial Delivery ManagementPosition 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 Pharmeceutical, 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 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.
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Required 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
