eCOA Project Manager, Clinical Trials, eCOA Technologies

Clinical OperationsClinical OperationsFull TimeRemoteMid LevelTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Mexico

Posted

2 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglish

Job Description

eCOA Project Manager, Clinical Trials, eCOA Technologies

Syneos Health

• responsible for the end-to-end planning, implementation, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions across assigned clinical trials • serves as the primary point of accountability for eCOA delivery, ensuring systems are configured, validated, deployed, and maintained • partners closely with Clinical Operations, Data Management, Biostatistics, vendors, and sponsors to deliver high quality, patient centric electronic assessment solutions • leads eCOA delivery activities from startup through clos-out, including requirements gathering, system build, UAT script writing, UAT conduct, ongoing maintenance, etc • collaborates with internal stakeholders and sponsor

Job Requirements

  • at least 2 years of experience in Clinical Trials & eCOA technologies
  • Subject matter expertise in eCOA technologies and patient reported outcomes
  • Strong project and vendor management skills
  • Excellent communication and stakeholder engagement abilities
  • High attention to detail with a quality focused mindset
  • Ability to proactively identify risks and drive solutions

Benefits

  • We are passionate about developing our people, through career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • We are committed to building an inclusive culture – where you can authentically be yourself

Related Categories

Related Job Pages

More Clinical Operations Jobs

Full TimeRemoteTeam 10,001+Since 1956H1B Sponsor

• Manage staff, providing coaching, mentorship and work direction. • Conduct regular performance appraisals and career discussions with staff. • Facilitates employee career development. • Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. • Supports allocation activities per the local resourcing process. • Supports activities of project leads/functional leads to optimize the operational running of projects. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. • Identifies training gaps and ensures that training requirements are met. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

North Carolina

Case Research & Coordination Lead

The Workforce Group

The Workforce Group a LEMOINE company is a Great Place to Work® Certified company. We are a team of dedicated professionals that pull together to meet the needs of communities partnering with federal, state, and local governments. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration without regard to race, color, sex, national origin, age, protected veteran status, or disability status.

Role Description This is a remote position. The Workforce Group, a LEMOINE company, is seeking a detail-oriented Case Research & Coordination Lead to support a nationwide federal human services program serving vulnerable populations, including youth, young adults, and families. This role leads: - Address research - Address verification - Case coordination function - Case intake oversight - Location research - Case queue management - Field assignment coordination - Documentation tracking - Follow-up support The Case Research & Coordination Lead is accountable for the quality and timeliness of the team's work. Address determinations must meet the standard of confidence-scored, documentable, and defensible findings. This position requires strong research skills, accurate documentation, sound judgment, confidentiality, and the ability to manage multiple case actions in a fast-paced, deadline-driven environment. Qualifications - High school diploma or equivalent required. - Minimum three years of experience in records research, address validation, case coordination, dispatch, scheduling, records review, human services support, field operations support, including at least one year in a lead, supervisory, or senior coordination capacity. - Experience leading or supporting field-based operations teams or geographically dispersed programs is highly preferred. - Experience supporting vulnerable populations, youth, young adults, families or culturally diverse communities. - Strong attention to detail and ability to review information for accuracy, completeness, and consistency. - Strong documentation and communication skills; ability to prepare and review objective and accurate records. - Demonstrated ability to lead, train, and direct a team toward accuracy and timeliness standards. - Ability to lead and manage multiple cases, deadlines, priorities, and follow-up actions simultaneously. - Strong verbal and written communication skills. - Ability to maintain confidentiality, professional boundaries, and ethical standards at all times. - Ability to work independently and exercise sound judgment in a fast-paced operational environment. - Ability to learn and use approved case management, mapping, routing, research, or documentation tools. - Ability to complete required federal, client, and company training prior to assignment. - Ability to pass and maintain a government security background investigation, including a favorable credit check. - Proficiency using Microsoft Office, email, spreadsheets, shared trackers, databases, and electronic documentation systems. - Must pass a drug test, motor vehicle record check, and background check after accepting a conditional offer. - Bilingual fluency in English and Spanish is strongly preferred. - Training or experience in trauma-informed care, de-escalation, crisis response, mandated reporting, safety planning, or similar practices is strongly preferred. - Must be authorized to work in the United States. - U.S. Citizenship is required for this position due to significant PII/SPII and Government case-data access. Requirements - Lead daily operations of the address research, address verification, and case coordination function, setting work queue priorities and balancing workload across analysts and coordinators. - Oversee address development, redevelopment, and verification to ensure determinations are made using approved tools, records, databases, and that each is supported by documented research steps, source rationale, and confidence scoring. - Review and approve case determinations, escalations, and rework; serve as the escalation point for complex, conflicting, or high-priority cases. - Coordinate movement of cases through research, field assignment, quality review, data entry, language access, and reporting stages. - Direct case routing to field teams based on geography, urgency, language needs, revisit probability, travel considerations, and operational capacity. - Own monitoring of case milestones and 10-calendar-day timeliness deadlines; identify at-risk cases early and drive corrective action. - Supervise, train, and develop Address Research/Location Analysts and case coordination staff. - Monitor individual and team performance against accuracy and timeliness standards. - Direct redeployment and follow-up activity when a participant is not located, and address changes, or additional information is needed. - Maintain accurate case coordination documentation, communication logs, assignment records, and status reporting in approved systems, trackers, forms, or databases. - Identify potential documentation gaps, conflicting information, duplicate records, or incomplete case information and implement corrective measures. - Partner with program leadership, field operations, quality review, language access, and data/reporting functions to support timely, accurate case progression. - Protect sensitive participant, program, and Government-related information. - Maintain professional, objective, and accurate documentation without unsupported conclusions or personal opinions. - Participate in required training, operational briefings, quality assurance activities, and staff meetings. - Perform additional duties as assigned. Benefits - Employment is contingent upon successful completion of all pre-employment screening requirements, including background checks, drug screening, motor vehicle records review, reference checks, and other job-related screening requirements. - Employment is also contingent upon successful completion of required federal background/suitability review, favorable credit check, security processing, and program-specific onboarding before beginning work. - Employees assigned to this program must complete required training, protect sensitive information, comply with standards of conduct, maintain professional boundaries, and follow all reporting, confidentiality, privacy, and information security requirements. - Employees may be required to sign confidentiality, non-disclosure, conflict-of-interest, and standards-of-conduct acknowledgments.

United States
Talkiatry logo

General Manager/Director of Clinical Operations, Psychiatry

Talkiatry

Talkiatry is a digital platform that offers accessible, affordable mental healthcare. The company’s past flexible job postings have offered 100% remote flexib

Role Description We are seeking a General Manager / Director of Clinical Operations, Psychiatry to own and oversee the day-to-day activities for a team of clinicians. This role will have control over the supply and demand sides of our business to find the sweet spot between provider flexibility and operational efficiency. To that end, you will be responsible for: - Utilization management - Capacity planning - Adherence to care protocol - Billing consistency - Cost control In essence, you will be a business owner accountable for revenue growth and cost and quality control. This role is highly cross-functional and collaborative. You will be working with clinicians as your main internal clients but will partner with Product and Tech, Clinical Support, and other centralized operational functions. You will be frequently: - Strategizing on long-term goals - Problem-solving day-to-day inefficiencies of our operations - Interpreting performance and quantitative data - Running projects to improve our experience and care quality If you are passionate about running a business and enabling clinicians in serving mental health needs, we encourage you to apply for this exciting opportunity. This role is one of the most integral parts of Talkiatry’s next chapter! Qualifications - 5-10 years of experience in operations, driving results across diverse business sectors and/or at high growth healthcare companies - Bachelor’s degree, preferably Master of Business Administration or Healthcare Management - Background in banking or consulting, experience honing strong analytical skills paired with the ability to execute operational tactics and measure impact in an unbiased way - Exceptional presentation and communication skills with the ability to motivate and inspire diverse audiences, both clinical and non-clinical - Willingness to travel occasionally for in-office work, conferences, and regional events - Passion for mental health care delivery and the desire to use your talents to help the hands that heal, supporting our clinicians professionally in an ever-changing environment Requirements - Partner with clinical leaders in a dyad leadership to implement policies, programs, and procedures to achieve objectives across quality, growth, efficiency, and experience - Ensure consistency of service delivery by rolling out new processes and/or enhancing adoption of new technology features - Sustain current performance with existing data tools and process playbook, while stretching towards higher targets as we innovate as a company - Use a structured, data-driven approach to solve old problems in new ways (e.g. patient matching & scheduling, late cancel and no show policies, care plan adherence, clinical documentation flows, etc.) - Work closely with Analytics & Insights and Program Management to scale regional solutions for practice-wide adoption - Partner with Strategic Operations and Marketing to engage referral partners and specialty patient populations - Lead by example, fostering a culture of empathy, service, collaboration, accountability, and inclusion Benefits - Top-notch team: we're a diverse, experienced group motivated to make a difference in mental health care - Collaborative environment: be part of building something from the ground up at a fast-paced startup - Excellent benefits: medical, dental, vision, effective day 1 of employment, 401K with match, generous PTO plus paid holidays, paid parental leave, and more! - Grow your career with us: hone your skills and build new ones with our Learning team as Talkiatry expands - It all comes back to care: we’re a mental health company, and we put our team’s well-being first

United States
$165K - $175K / year
Tempus AI logo

Vice President, Clinical Development Operations

Tempus AI

Tempus is advancing data-driven precision medicine with the practical application of AI in healthcare. It’s About Time.

Full TimeRemoteTeam 1,001-5,000Since 2015H1B No Sponsor

• Hold primary accountability for the operational planning, management, and execution of clinical trials designed for clinical evidence generation. • Drive performance against key trial metrics, including site activation, patient enrollment, data quality, budget adherence, and alignment with corporate goals and regulatory requirements. • Develop and implement optimized operational strategies to enhance trial efficiency, reduce complexity, and accelerate data delivery timelines. • Actively participate in budget planning, financial forecasting, and resource allocation for the evidence generation operations unit to ensure optimal performance. • Collaborate closely with Biostatistics and Data Management teams to ensure the timely, accurate, and high-quality flow of trial data into the clinical database, facilitating efficient data cleaning, analysis, and database lock. • Interact closely and establish seamless workflows with cross-functional leaders to ensure that clinical trial data from all sources is accurately captured and reconciled. • Lead, mentor, and develop a high-performing operations team capable of managing a focused portfolio of clinical evidence generation studies. • Serve as the primary operational leader for evidence generation trial conduct, ensuring tight alignment and communication with Clinical Development, Regulatory Affairs, Project Management, and other key stakeholders. • Ensure all evidence-generation trial activities are conducted in strict accordance with Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards. • Maintain a constant state of inspection readiness for all evidence-generation clinical trials and support senior leadership during regulatory authority inspections (e.g., FDA).

United States