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US 3w PTO

  • Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team.
  • Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation.
  • Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s.

Clinical Operations Vendor Management Process Improvement

20 jobs similar to Associate Director, Clinical Operations Standards and Planning

Jobs ranked by similarity.

US Unlimited PTO 17w maternity 9w paternity

  • Leads the Clinical Study Team for assigned projects from concept to protocol.
  • Manages external vendors and contract research organizations.
  • Manages operational activities at the study level and monitoring activities at clinical study sites to assure adherence to GCP, SOPs, and study protocols.

BridgeBio is committed to discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases with unmet needs. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

$155,000–$180,000/yr
US

  • Lead and manage the day-to-day operational execution of assigned cell therapy trials.
  • Develop and manage study timelines, budgets, forecasts, and related operational metrics.
  • Partner with external vendors / CROs / service providers to ensure high quality and timely deliverables.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and are guided by their core values.

US

  • Act as a program lead for the SVP, structuring ambiguous operational challenges, defining solutions, and driving high-impact initiatives from decision to execution.
  • Own the Clinical Ops leadership "front door," including intake and triage; run the operating rhythm and maintain core artifacts, including the OKR tracker and Initiative log.
  • Act as the critical link between Clinical Ops and partners (Quality/Safety, Product, Finance, HR) to unblock progress, resolve ownership/resourcing gaps, and coordinate complex rollouts.

Midi Health is a fast-scaling virtual care company focused on women’s health, transforming healthcare delivery through a modern, tech-forward platform and a distributed clinical team. The company seems to have a modern, tech-forward culture driven by innovation.

US

  • Serve as leader of the local study team on assigned studies.
  • Manage and maintain accurate country level plans including timelines and budgets.
  • Implement startup and site activation plans at various levels.

Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly. They identify top-fitting candidates and shares this shortlist directly with the hiring company.

$100,675–$151,192/yr
Europe

  • Ensure the development and implementation of action plans.
  • Lead regional/therapeutic area project resourcing.
  • Develop, mentor, manage and coach GCM Managers.

Precision for Medicine is a global precision medicine clinical research services organization. They improve the clinical research and development process for new therapeutics by integrating clinical operations excellence, laboratory expertise, and advanced data sciences.

$140,000–$170,000/yr
US

  • Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
  • Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
  • Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.

$100,000–$120,000/yr
US

  • Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
  • Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
  • Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.

Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.

US

  • Provide strategic and administrative leadership for clinical research business and operational activities.
  • Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
  • Drive operational performance, program growth, and team development across the clinical research enterprise.

Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.

US

  • Oversee and manage regional operational activities of global pivotal trials.
  • Develop and oversee procedures for troubleshooting and problem solving.
  • Maintain effective communication with vendors and internal departments.

Prilenia is a private biopharmaceutical company focused on developing transformative medicines for neurodegenerative diseases. With a highly committed and talented global team, they are developing pridopidine, an investigational neuroprotective therapy for ALS and Huntington’s disease.

Europe

  • Management and operational delivery of clinical elements within a trial.
  • Successful execution of assigned trials and ensuring completion of deliverables.
  • Identify challenges to study timelines and offer creative action plans.

Precision for Medicine is a precision medicine CRO, integrating novel clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They are passionate about rare diseases and oncology, working across other therapeutic areas, with high-energy, dedicated professionals.

US

  • Build and operationalize a scalable clinical trial site management model leveraging IVX Health’s clinical and operational infrastructure.
  • Lead execution of clinical trials across multiple sites, ensuring protocol adherence, predictable study start‑up, and high‑quality administration and documentation.
  • Serve as the senior accountable leader for regulatory compliance, quality, SOP governance, training, documentation integrity, and CAPA.

IVX Health is a national leader in high‑quality infusion and injection therapy, operating 150+ ambulatory centers across the U.S. They are backed by Linden Capital Partners and continue to scale rapidly—expanding services, accelerating growth, and building the leading ambulatory infusion platform in the country.

Europe

  • Lead, mentor, coach, and manage Clinical Trial Managers to support skill development and career growth.
  • Partner with Clinical Operations leadership and cross-functional teams to improve processes and quality.
  • Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.

Precision for Medicine is a clinical research company. They focus on improving the quality and productivity of clinical trial management operations.

US

  • Design and build foundations for initiatives within the Clinical Operations function.
  • Collaborate cross-functionally to build scalable products and processes.
  • Assess and analyze data to develop strategies for accelerating progress.

Headway's mission is to build a new mental healthcare system accessible to everyone. They are a Series D company with over $325m in funding and have grown into a diverse, national network of over 60,000 mental healthcare providers across all 50 states.

$155,000–$183,000/yr

  • Responsible for operational oversight of the site, site health and monitoring activities.
  • Support sites in understanding study expectations, timelines, and required deliverables.
  • Build and maintain strong, trusted relationships with investigators and site staff.

CSL Behring is a global biotherapeutics leader committed to saving lives. They focus on serving patients’ needs by using the latest technologies to discover, develop, and deliver innovative therapies. CSL's parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

Unlimited PTO

  • Senior leadership for enterprise clinical programs.
  • Accountability for clinical quality performance.
  • Translating clinical priorities into scalable operating models.

Evergreen Nephrology partners with nephrologists to transform kidney care through a value-based, person-centered, holistic, and comprehensive approach. They are committed to improving patient outcomes and quality of life by delaying disease progression, shifting care to the home, and accelerating kidney transplants.

US

  • Work cross functionally to develop partnership strategies for clinical trials and programs.
  • Provide leadership and oversight on all clinical programs.
  • Optimize the profitability of the Project Management organization to meet or exceed budget targets.

Precision Medicine Group is a company that works in the clinical trial and program development space. We empower pharmaceutical and life sciences companies to accelerate their drug development, research, and commercialization endeavors.

Europe Middle East Africa

  • Serve as the primary Project Manager for Global (Non US) Clinical Training and Programming
  • Develop and implement a Global Clinical Training and Programming strategy that is sustainable for continued growth
  • Work closely with large Jumbo customers to consult on Training and Programming planning, including partnering with internal stakeholders to consult, manage and advise customers.

Spring Health is on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need, when they need it. They partner with over 450 companies and provide care for 10 million people.

$250,000–$350,000/yr
US

  • Drive operational excellence, consistency, and enterprise value across a multi-state behavioral health organization.
  • Lead the design and execution of strategies that optimize the operating model.
  • Oversee clinical operations, service delivery, staffing performance, and infrastructure across multiple levels of care.

Accanto Health provides exceptional, individualized care that leads to lasting recovery for eating disorders. They are a multi-state behavioral health organization composed of compassionate, dedicated professionals from a variety of backgrounds who collaborate to provide the very best evidence-based care.

US

  • This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
  • Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
  • Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people’s lives across several therapeutic areas including immunology, oncology and neuroscience.

$164,900–$197,500/yr
US 13w maternity 11w paternity

  • Own the end-to-end performance, and evolution of Spring Health’s 24/7 Crisis Line, Critical Incident Response (CIR), Mandatory Referral, and Manager Consultation services.
  • Translate enterprise customer needs and clinical quality requirements into scalable clinical operating models.
  • Partner cross-functionally with Product, Care Support, Customer Success, Legal, Network Operations, and Business Intelligence to continuously enhance service delivery and the member experience.

Spring Health is on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need. They partner with over 450 companies and provide care for 10 million people.