EMD Serono
Associate Director, Trial Clinical Operations Delivery Lead
EMD Serono, Billerica, Massachusetts, us, 01821
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
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.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit
this link .
#J-18808-Ljbffr
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
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.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit
this link .
#J-18808-Ljbffr