Manager, Trial Delivery Management
vor 5 Monaten
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 Medical 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, be 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.
**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.
Foster employee engagement, inclusion, and Credo Behaviors.
**Qualifications**:
**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 the pharmaceutical industry.
**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. Operates and executes with limited supervision. Experience mentoring/coaching others.
Strong project planning/management, communication and presentation skills are required.
About Johnson & Johnson
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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