Job Function: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category:Professional
All Job Posting Locations:Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:The Lead, 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).
- Manage 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.
Education and Experience Requirements: - BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology,
- Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
- Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
- 2-3 years' experience supporting multiple aspects of a global clinical trial.
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience 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.
- Travel up to 15-20% of the time, defined by business needs.
- Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
