Senior Clinical Project Manager
EDETEK, Inc., Brazil, IN, United States
EDETEK is seeking an experienced and highly motivated Senior Clinical Project Manager to lead the planning, execution, and oversight of clinical trials for pharmaceutical, biotechnology, and medical device clients. This role is responsible for cross-functional project leadership from study startup through closeout, with a strong focus on timeline management, sponsor communication, risk management, vendor oversight, and quality delivery.
The ideal candidate will bring solid experience in a CRO environment and hands‑on experience coordinating Data Monitoring Committee (DMC) activities, including meeting planning, deliverable readiness, communication management, and follow‑up tracking. This individual must be able to manage multiple stakeholders, work effectively in a matrixed environment, and ensure studies are delivered on time, within scope, and in compliance with applicable regulations and company procedures.
Essential Functions and Responsibilities
Lead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations.
Serve as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships.
Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers.
Coordinate cross‑functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams.
Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow‑up on action items.
Monitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed.
Oversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations.
Support budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders.
Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable.
Promote effective communication and collaboration across global teams and functions.
DMC Coordination Responsibilities
Lead or support the coordination of Data Monitoring Committee activities for assigned studies.
Develop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools.
Coordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions.
Monitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials.
Organize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow‑up activities.
Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls.
Ensure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures.
Maintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.
Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field required. Advanced degree preferred.
Minimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO industry.
Strong experience working in a CRO environment with sponsor‑facing project responsibilities.
Demonstrated experience coordinating or supporting DMC or IDMC activities in clinical trials.
Strong understanding of ICH‑GCP, clinical trial operations, and applicable regulatory requirements.
Proven ability to manage multiple projects, priorities, and stakeholders in a fast‑paced environment.
Experience with study risk management, vendor oversight, and issue escalation.
Strong organizational, analytical, and problem‑solving skills.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project tracking tools.
Ability to work effectively with global teams across multiple time zones.
Occasional travel may be required based on project or client needs.
Preferred Qualifications
Experience in oncology, rare disease, CNS, immunology, or other complex therapeutic areas.
Experience managing global or multi‑regional clinical trials.
Familiarity with biometrics‑related deliverables, including data review, interim analysis support, and reporting packages for DMC meetings.
Experience working with decentralized trial tools, eClinical platforms, or integrated technology‑enabled clinical solutions.
Core Competencies
Clinical project leadership
Sponsor relationship management
DMC coordination
CRO operations
Vendor oversight
Risk identification and mitigation
Cross‑functional collaboration
Timeline and budget management
Quality and compliance focus
Decision‑making and accountability
Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.
Choice of comprehensive Medical, Vision and Dental Insurance plans
Paid vacation time and sick days
Corporate holidays annually
Participation in the 401K Plan
Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
Health Advocate and Employee Assistance Program
Location:
This is a remote position, and we are open to candidates based in the United States, Argentina, and Brazil.
Equal Opportunity Employer Statement
EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.
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The ideal candidate will bring solid experience in a CRO environment and hands‑on experience coordinating Data Monitoring Committee (DMC) activities, including meeting planning, deliverable readiness, communication management, and follow‑up tracking. This individual must be able to manage multiple stakeholders, work effectively in a matrixed environment, and ensure studies are delivered on time, within scope, and in compliance with applicable regulations and company procedures.
Essential Functions and Responsibilities
Lead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations.
Serve as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships.
Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers.
Coordinate cross‑functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams.
Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow‑up on action items.
Monitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed.
Oversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations.
Support budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders.
Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable.
Promote effective communication and collaboration across global teams and functions.
DMC Coordination Responsibilities
Lead or support the coordination of Data Monitoring Committee activities for assigned studies.
Develop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools.
Coordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions.
Monitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials.
Organize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow‑up activities.
Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls.
Ensure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures.
Maintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.
Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field required. Advanced degree preferred.
Minimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO industry.
Strong experience working in a CRO environment with sponsor‑facing project responsibilities.
Demonstrated experience coordinating or supporting DMC or IDMC activities in clinical trials.
Strong understanding of ICH‑GCP, clinical trial operations, and applicable regulatory requirements.
Proven ability to manage multiple projects, priorities, and stakeholders in a fast‑paced environment.
Experience with study risk management, vendor oversight, and issue escalation.
Strong organizational, analytical, and problem‑solving skills.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project tracking tools.
Ability to work effectively with global teams across multiple time zones.
Occasional travel may be required based on project or client needs.
Preferred Qualifications
Experience in oncology, rare disease, CNS, immunology, or other complex therapeutic areas.
Experience managing global or multi‑regional clinical trials.
Familiarity with biometrics‑related deliverables, including data review, interim analysis support, and reporting packages for DMC meetings.
Experience working with decentralized trial tools, eClinical platforms, or integrated technology‑enabled clinical solutions.
Core Competencies
Clinical project leadership
Sponsor relationship management
DMC coordination
CRO operations
Vendor oversight
Risk identification and mitigation
Cross‑functional collaboration
Timeline and budget management
Quality and compliance focus
Decision‑making and accountability
Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.
Choice of comprehensive Medical, Vision and Dental Insurance plans
Paid vacation time and sick days
Corporate holidays annually
Participation in the 401K Plan
Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
Health Advocate and Employee Assistance Program
Location:
This is a remote position, and we are open to candidates based in the United States, Argentina, and Brazil.
Equal Opportunity Employer Statement
EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.
#J-18808-Ljbffr