Trial Clinical Delivery Lead

Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-DPN N&I, Fert, CM, Endo Delivery
Recruiter: Sarah Ellis

This information is for internals only. Please do not share outside of the organization.

Your role:

• Accountable for the delivery and quality of site level activities in Phase I-IIIb Clinical Development studies; act as link between Clinical Site Leads (CSLs), Global functions & CRO counterparts - single point of contact for site management & operational topics/escalations; support information channeling and issue resolution for the study
• Provide leadership, strategic direction, and operational oversight for Clinical Site Lead (CSL) activities across assigned study(ies) in response to quality and performance oversight measures and trends.
• Serve as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focused accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate
• Facilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions.
• Ensure timely and appropriate escalation of trends, issues, and risks within the Clinical Operations Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate.
• Promote solution-orientated thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure study-specific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners.
• Support product and study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills.
• Promote Product Knowledge ensuring all team members understand trial assets and protocols. Foster Collaboration: Encourage regular communication and teamwork between sites and stakeholders.
• Streamline Information Sharing: Use clear channels to share updates and information.
• Develop Best Practices: Contribute to and follow guidelines for consistent site and study management.
• Lead regular calls with CSLs working on study and/or other activities within the assigned study(ies)
• Act as functional lead for process improvement initiatives

As a member of the Clinical Trial Team:

• Represent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via:
  • Regular review meetings of study/site performance and quality metrics and the associated strategic action planning
  • Ad hoc interactions to address immediate issues.
  • Other COT/CTT meetings as appropriate e.g., kick-off meeting
• Consolidate and assess data-driven proposals for selecting countries and sites, ensuring quality and consistency across regions. Provide clear, actionable information to Clinical Trial Teams (CTTs) to support their decision-making and keep Clinical Site Leads (CSLs) informed of the final selection of regions, countries, and sites.
• Lead activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct e.g., utilizing Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organizations etc.
• Design country start-up strategy in consultation with the Start-up Solutions Team and Country Start-up Specialists (CSS), and in alignment with the CTL(s) and CRO(s). Work closely with the CSL to oversee and ensure delivery at the site and country level.
• Design patient and site centric recruitment and retention strategies, in consultation with the CTL and CRO/Vendor(s), and in alignment with the study and company diversity and inclusion objectives:
  • Lead identification and implementation of optimal solutions, considering program and study characteristics, with clearly delineated key performance indicators to deliver tangible impact and drive study execution e.g., utilizing digital channels, biomarker-driven recruitment services and Decentralized Clinical Trial (DCT) capabilities such as telemedicine, mobile health applications, wearable sensors, direct to patient medication, etc.
  • Oversee service providers to ensure successful implementation within agreed timelines, budget, and quality.
• Develop and implement a monitoring strategy in collaboration with Clinical Trial Leads (CTLs) and Contract Research Organizations (CROs), using a risk-based quality management approach. Continuously update the strategy based on external changes and new internal data.
• Utilize site performance and quality data analytics to drive proactive, risk-based site oversight practices and quality risk oversight and management across all stages of study delivery.
  • Develop, implement, and follow up on robust Site Oversight Plans, in collaboration with the CTL(s) and working closely with the respective CSLs.
  • Identify and encourage use of data-driven oversight tools and methods at the site and study level.
  • Identify trends and issues within/across assigned study(ies) which may impact key study deliverables (e.g., timelines/quality/costs) and work with CSLs, CTLs, Data Managers, Clinical Lead(s) and other relevant business partners to implement action plans to resolve and/or mitigate.
• Participate in Investigator/Study Coordinator Meetings and promote information sharing with the CSLs as needed.

Location: Hybrid/Remote within the United States:

Travel: Position may require domestic/international travel up to 20% of time.

Minimum Requirements:

• Bachelor's Degree Medical or Life Sciences degree in a clinical research related discipline or equivalent with 10+ years of experience.
• Clinical operations experience
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations

Preferred Requirements:

• Oncology and/or Neurology and/or Immunology TA experience desired
• (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct.
• Exhibit strong interpersonal skills: Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge, and cultural awareness to effectively lead and collaborate with diverse teams.
• Ability to work independently on assigned tasks or projects.
• Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
• Ability to assess risk, solve problems and take decisions.
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way.
• Comfortable working in a fast-paced environment where speed is paramount.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.