Associate Director, Trial Clinical Delivery Lead (all genders)
Associate Director, Trial Clinical Delivery Lead (all genders)

Associate Director, Trial Clinical Delivery Lead (all genders)

Vollzeit 72000 - 100000 € / Jahr (geschätzt) Kein Home Office möglich
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Auf einen Blick

  • Aufgaben: Lead global clinical trials, ensuring site performance and innovative solutions.
  • Arbeitgeber: Join a dynamic Global Clinical Operations team focused on modernizing clinical trials.
  • Mitarbeitervorteile: Enjoy hybrid/remote work options and opportunities for travel.
  • Warum dieser Job: Make a real impact in clinical research while collaborating with diverse teams.
  • GewĂĽnschte Qualifikationen: Bachelor’s in Medical or Life Sciences; 8-10 years in clinical operations required.
  • Andere Informationen: Preferred experience in Oncology, Neurology, or Immunology; strong communication skills essential.

Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.

We are looking for a highly skilled and strategic Project Manager to join our Global Clinical Operations team and lead the delivery of complex global clinical trials. In this role, you will provide leadership and strategic direction to optimize site performance at the global study level, overseeing site and vendor performance while ensuring proactive risk mitigation. You will play a critical role in modernizing the clinical trials under your responsibility by driving innovative, value-adding solutions and ensuring the adoption of cutting-edge methodologies. Additionally, you will be responsible for developing and executing effective site and patient engagement strategies to secure timely recruitment and retention, ensuring on-time study delivery and successful trial outcomes. As part of our global team, you’ll collaborate across functions to uphold high-quality standards and ensure clinical trials are executed efficiently with a patient-centric approach.

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, EST timezone preferred.

    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.
    • 8-10 years professional and project management experience in delivering Clinical Operations of global clinical trials required.
    • 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.
    • Experience in clinical operations 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.

    #J-18808-Ljbffr

    Associate Director, Trial Clinical Delivery Lead (all genders) Arbeitgeber: Merck Gruppe

    Join our dynamic Global Clinical Operations team, where we prioritize innovation and collaboration in delivering complex global clinical trials. As an Associate Director, you'll benefit from a supportive work culture that fosters professional growth and encourages the adoption of cutting-edge methodologies, all while enjoying the flexibility of a hybrid/remote work environment within the United States. With opportunities for meaningful impact and a commitment to patient-centric strategies, this role offers a rewarding career path in a forward-thinking organization.
    M

    Kontaktperson:

    Merck Gruppe HR Team

    StudySmarter Bewerbungstipps 🤫

    So bekommst du den Job: Associate Director, Trial Clinical Delivery Lead (all genders)

    ✨Tip Number 1

    Make sure to highlight your experience in managing global clinical trials, especially in Phase I-IIIb studies. Use specific examples of how you've optimized site performance and mitigated risks in previous roles.

    ✨Tip Number 2

    Demonstrate your leadership skills by discussing instances where you provided strategic direction to teams or projects. Emphasize your ability to foster collaboration among diverse stakeholders, including Clinical Site Leads and CROs.

    ✨Tip Number 3

    Showcase your knowledge of innovative methodologies and technologies in clinical trials. Mention any experience with decentralized clinical trial capabilities or patient engagement strategies that you've successfully implemented.

    ✨Tip Number 4

    Be prepared to discuss your analytical skills and how you've used data-driven insights to improve study execution. Highlight any tools or methods you've employed for site oversight and quality management.

    Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Associate Director, Trial Clinical Delivery Lead (all genders)

    Project Management
    Clinical Operations Expertise
    Risk Management
    Data Analysis
    Site Management
    Regulatory Knowledge (ICH GCP)
    Interpersonal Skills
    Strategic Thinking
    Problem-Solving Skills
    Communication Skills
    Adaptability and Flexibility
    Analytical Skills
    Therapeutic Area Knowledge (Oncology, Neurology, Immunology)
    Collaboration and Teamwork
    Patient Engagement Strategies
    Operational Excellence
    Monitoring Strategy Development
    Performance Metrics Assessment
    Decision-Making Skills

    Tipps für deine Bewerbung 🫡

    Tailor Your CV: Make sure your CV highlights relevant experience in clinical operations and project management. Emphasize your leadership roles and any specific achievements in delivering global clinical trials.

    Craft a Compelling Cover Letter: In your cover letter, express your passion for clinical research and your strategic vision for optimizing site performance. Mention specific methodologies or innovative solutions you have implemented in past roles.

    Showcase Relevant Skills: Highlight key skills such as critical thinking, strong communication, and adaptability. Provide examples of how you've successfully led teams or managed complex projects in the past.

    Demonstrate Cultural Awareness: Given the global nature of the role, mention any experience you have working with diverse teams or in different cultural contexts. This will show your ability to collaborate effectively across functions.

    Wie du dich auf ein Vorstellungsgespräch bei Merck Gruppe vorbereitest

    ✨Showcase Your Project Management Skills

    Be prepared to discuss your experience in managing complex global clinical trials. Highlight specific projects where you successfully led teams, optimized site performance, and mitigated risks.

    ✨Demonstrate Leadership and Strategic Thinking

    Illustrate your ability to provide strategic direction and operational oversight. Share examples of how you've driven innovative solutions and improved processes in previous roles.

    ✨Emphasize Collaboration and Communication

    Since this role involves working with various stakeholders, be ready to talk about your experience in fostering collaboration. Discuss how you maintain clear communication channels and resolve issues effectively.

    ✨Prepare for Data-Driven Discussions

    Given the emphasis on data analytics in this position, come equipped with examples of how you've used data to drive decision-making and improve study execution. Be ready to discuss specific metrics and outcomes.

    Associate Director, Trial Clinical Delivery Lead (all genders)
    Merck Gruppe
    M
    • Associate Director, Trial Clinical Delivery Lead (all genders)

      Vollzeit
      72000 - 100000 € / Jahr (geschätzt)

      Bewerbungsfrist: 2027-03-27

    • M

      Merck Gruppe

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