Job DescriptionThe Delivery Lead (DL) is responsible for supporting the design strategy for patient recruitment & retention within our clinical programs. The Delivery Lead (DL) will have assigned area(s) of focus (e.g., novel recruitment, patient facing content) within the Patient Engagement, Enrollment, and Retention (PEER) team. This role is responsible for supporting different design strategies in alignment with clinical and functional counterparts to gain efficiency and speed.
The Delivery Lead (DL) is responsible for the end-to-end coordination, execution, and quality oversight of Recruitment & Retention (R&R) materials and appreciation item workflows in support of clinical trials. The DL ensures timely delivery of trial ready materials by coordinating across functions, managing vendors, overseeing documentation and approvals, and maintaining clear communication with global and country stakeholders.
The DL plays a key role in ensuring readiness for FPV/LPV and contributes directly to clinical trial success.
Key Responsibilities:
1. Support the design strategy for clinical programs where the voice of the patient and researchers are represented
The Associate will:
• support the creation of the design strategy for patient recruitment and retention with the assigned area(s) of focus (e.g., novel recruitment, patient facing content).
• partner with PEER team colleagues and appropriate Clinical Design Delivery & Analytics (CDDA) functions to deliver the best strategic direction for each clinical program.
• support the creation of the appropriate deliverables (e.g., novel recruitment, patient-facing content) in partnership with PEER team colleagues as well as the functional owners and/or vendors.
• understand specific capabilities and access points to maintain key platforms and systems in support of the PEER team based upon the assigned area(s) of focus
2. Ensure continuous improvement by understanding the external needs and challenges of patients and researchers in addition to the internal needs and challenges of our clinical programs
The Associate will:
• contribute to a culture of partnership and shared learning across the PEER team and broader CDDA to identify best practices and standardized approaches to processes.
• work closely with PEER team members to continue to evolve internal standards, processes, tools, and best practices.
• continuously assess and evaluate evolving business partner needs that could be addressed by process improvements, standardization, or automation.
3. Contribute to a team culture that is valued for strategic and technical leadership
The Associate will:
• provide strategic and technical support to ensure that processes for the assigned area(s) of focus are well integrated within the appropriate CDDA functions.
• support the delivery of right-sized design strategies that can be successfully implemented in our clinical programs.
Core Competencies:
1. Project Management & Execution
• Plans, manages, and tracks complex multi step workflows from protocol approval through translation, IRB/ERB submissions, proofing, printing, and distribution.
• Maintains accurate documentation across strategy documents, trackers, dashboards, and SharePoint environments.
2. Cross Functional Collaboration
• Works effectively with CRLs, CDTLs, SDLs, TCs, TCAs, CTP PMs, SMT, HLC, vendors, and operational teams.
• Facilitates alignment on vendor selection, timelines, and submission milestones.
3. Vendor & External Partner Management
• Coordinates translation vendors, print vendors (e.g., Hibbert), and digital campaign vendors.
• Reviews quotes, summarizes recommendations, and obtains stakeholder alignment.
4. Documentation, Version Control & Quality Assurance
• Applies versioning codes and ensures file naming accuracy.
• Conducts QC checks on translated materials, print proofs, and final print ready files.
• Ensures correct routing and approval in eTMF and SharePoint.
5. Regulatory & Submission Competency
• Understands IRB/ERB requirements and supports local submission needs.
• Ensures materials reach medical approval prior to country submission.
6. Communication & Stakeholder Influence
• Provides clear, concise email summaries, recommendations, and next steps.
• Communicates proactively with country teams to support submission need
7. Problem Solving & Issue Resolution
• Identifies gaps (e.g., missing materials) and proposes solutions.
• Manages delays in medical reviews, proofing, translation cycles, or external dependencies.
Other Details:Schedule: 40 hours/week
Work Setup: Hybrid (3 days onsite, 2 days remote - flexible) in Indianapolis, IN
Contract Length: 12 months - w/ possible extension
Travel: Minimal travel required
RequirementsRequired Qualifications:- Bachelor's degree in scientific or healthrelated field or equivalent
- 3+ years ofexperience in pharmaceutical industry or equivalent
Additional Preferences:- Understanding of the pharmaceutical drug/devicedevelopment process
- Demonstrated knowledge and experience withproject management tools and processes
- Proven ability to deliver to timelines
- Excellent communication (written and verbal)skills
- Demonstrated organizational and criticalthinking skills
- Ability to lead and influence toward a commongoal
- Minimal travel required
Benefits• Health Insurance: Eligibility to enroll in medical, dental, and vision insurance plans. You may also participate in a Flexible Spending Account (FSA) or Health Savings Account (HSA) for qualified healthcare and dependent care expenses.
• Voluntary Benefits: Option to enroll in employee-paid voluntary benefits, including life insurance, short- and long-term disability insurance, and long-term care insurance.
• 401(k) Plan: Eligibility to participate in the company's 401(k) retirement plan. Please note, this plan does not include an employer contribution.
• Commuter Benefits: Eligibility to participate in a commuter benefits program, allowing the use of pre-tax dollars for transit and/or parking expenses.
• Paid Time Off (PTO): You will accrue two weeks of vacation annually (prorated based on your start date), in addition to sick leave accrued in accordance with applicable state laws. You will also receive 11 company-paid holidays each year.
Note: Benefits will be effective after 30 days.
