Site Monitoring Lead / Clinical Operations Lead Job at Parexel

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Lead Clinical Site Ambassador

Accountable for the strategic and operational oversight of investigational site ...

Location

Salary:

Not provided

The Muse

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
10 years + clinical research experience within the pharmaceutical industry
Experience in leading / managing a team as well as in site management, monitoring and overseeing large and/or complex global clinical trials
Must have a strong understanding and experience in drug development process and specifically each step within the clinical trial process
Must have strong budget forecasting and management experience
Extensive experience and knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Experience / ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.

Job Responsibility

Accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs
Ensure that clinical trials are executed with high quality, regulatory compliance, and operational efficiency
Partner with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks
Maintain sponsor oversight, validating the effectiveness of study and site-level activities
Ensure that monitoring plans and tools adequately address protocol-specific risks
Build and manage meaningful productive relationships with KOLs and key investigator sites
Responsible for operational oversight of the site, site health and monitoring activities
Support QA audit and inspection planning, and implementation of CAPAs as needed
Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts

What we offer

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability
Long-Term Disability
FSA
HSA
Mental Health Benefits
Adoption Leave

Fulltime

Associate Director, Monitoring Oversight Management

We are seeking an Associator Director, Monitoring Oversight Management, to manag...

Location

United States

Salary:

180000.00 - 205000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
Minimum 5 years of experience leading a team of CRAs
Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
Experience working in Phase I – III clinical trials
Recent experience working on trials utilizing risk-based monitoring models
Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
Strong understanding of clinical trial processes and study conduct

Job Responsibility

Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials
Support contract Oversight CRAs globally
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs
Contribute to building a culture of team, site and patient centricity
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies
Leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality
Responsible for hiring in-house Oversight CRAs
Assist with creation, review and revision of departmental SOPs and policies
Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs
Assist with creation and delivery of department initiatives, improvement plans and/or training

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Campus Director, Clinical Education - Physician Assistant

The Campus Director of Clinical Education, Physician Assistant is a key member o...

Location

United States , Ontario

Salary:

138230.12 - 200406.07 USD / Year

American Career College

Expiration Date

Until further notice

Requirements

For PA and Physician Candidates: Minimum of three (3) years of teaching, research, or clinical experience in a PA program/Medical School, or equivalent*** experience in health professions education, healthcare delivery, or related fields that directly support PA student learning and curricular outcomes.
For Non-Clinician Scientist candidates: Minimum of one (1) year of full-time experience in PA education, academic support, or curriculum development in alignment with program needs.
Demonstrated the ability to develop clinical and didactic curriculum, program evaluation and student assessment.
Leadership knowledge in the program field to cultivate a learner-centered environment and to foster excellence.
Knowledge and evidence of strong supervisory and management skills as applicable to specialized program area.
Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance and other regulatory standards such as Title IV, WSCUC, and ARC-PA and other accreditation standards.
Physician Assistant/Associate (PA) Candidates: Graduation from an ARC-PA accredited PA program.
Master’s degree in education or a related health- or social-science discipline.
Current National Commission on Certification of Physician Assistants (NCCPA) certification or eligibility* to sit for the PANCE (initial certification) or PANRE (recertification) at the time of hire.
State PA licensure or eligibility* for licensure in state of campus location.

Job Responsibility

Collaborate as a member of the programmatic leadership team, which may consist of the MPA Dean/Program Director, Medical Director, Director of Academic Education, and Director of Student Success to achieve a shared vision for the program.
Collaborate with the MPA Dean/Program Director, Medical Director, and the WCU Clinical Operations team to develop, evaluate, and maintain clinical sites and preceptors sufficient in number and quality to meet ARC-PA Standards.
Communicate with MPA Dean/Program Director ongoing new site development and needed support to facilitate Program/Preceptor relationships, including support from the Medical Director.
Contacts, develops new and maintains established clinical affiliations, assuring all clinical sites meet the program’s prescribed learning outcomes, and securing appropriate contact and specific contractual agreement information including identified preceptors, number and types of placements, renewals, insurance and liability matters, and other pertinent issues important to seamless transition of students to clinical sites.
Prepares and submits to MPA Dean/Program Director annual program clinical calendar, individual student clinical placement schedule, and oversees preparation and formal distribution of student clinical placement assignments with detailed site, setting, and discipline-related information on timeline set by MPA Dean/Program Director.
Provide leadership, oversight, and performance evaluation for the clinical phase team, as assigned.
Develops, maintains, and conducts a schedule for clinical site visitation and presents a written copy to the MPA Dean/Program Director at a specified time each year with updated list of new and renewed affiliation agreements.
Develops, implements, stores, and updates as needed Clinical Site Visit Forms to ensure rapid retrieval and MPA Dean/Program Director and faculty access to documented site visits and/or phone calls.
Conduct clinical site visits and monitor student performance in Supervised Clinical Practice Experiences (SCPEs).
Lead the design, development, implementation, coordination and ongoing evaluation of an innovative clinical curriculum to ensure alignment with ARC-PA Standards, PAEA’s End-of-Rotation Exams, the NCCPA blueprint, and degree requirements.

What we offer

medical
dental
vision
flexible spending accounts
401(k) match
paid time off
holidays
parental leave
tuition reimbursement
adoption assistance

Fulltime

Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who wil...

Location

United States

Salary:

285000.00 - 320000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion
Minimum of 7 years line management experience
Minimum of 3 years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly
Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Manage and plan CTO resourcing for assigned programs
Lead, build and mentor CTO team supporting assigned program(s)
Serve as a member on Clinical Operations Leadership Team (COLT)
Create and support implementation of Clinical Operations processes, platforms and/or systems
Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
Clinical operations representative on Program Teams (PT)
Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans
Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
Strong collaboration and partnership with cross functional colleagues globally

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Multi-Site Manager

WellNow Urgent Care’s Multi-Site Manager position is responsible for leading two...

Location

United States of America , Bloomington

Salary:

60000.00 USD / Year

WellNow Urgent Care

Expiration Date

Until further notice

Requirements

3+ years of experience in healthcare environment and clinical experience preferred
May be required to work alternate shifts and may be required to float to other clinic locations
Will participate in weekend rotation within region as assigned by RDO
Ability to work both independently and in a team environment
Strong interpersonal and communication skills and the ability to work effectively with a wide range of people
Skill in organizing and establishing priorities
Must be detail-oriented and well organized
Microsoft Office experience
Must have reliable transportation
Ability to work flexible schedule including evenings and weekends

Job Responsibility

Monitors Practice Metrics
including patient satisfaction, patient visits and expenditures
identifies opportunities for improvement and executes improvement plans approved by Leadership
Ensure patients, visitors, medical staff, colleagues and others are treated with compassion and respect. Strives for excellent patient satisfaction
Places an emphasis on patient safety, quality, convenience and customer service
Supervises the orientation, training and cross training of clinic staff with the assistance of the clinical lead and provider to ensure that all competencies, policies, established practices and standards are followed and adhered to
Participates in the development and leads the execution of UC goals and objectives
Clearly communicates goals and objectives to employees in partnership with the clinical lead and provider
Responsible for employee timekeeping, attendance tracking, absence management, and approvals in a timely manner
Partners with Regional Practice Managers and Lead Providers to manage site staffing levels to ensure the office is adequately staffed to serve patients

What we offer

Competitive salary
Parental leave
Continuing education opportunities
Medical benefits, including vision coverage, FSA/HSA options, and prescription drug coverage
401(k) plan with a company match for your future financial security
Free urgent care visits for you and your immediate family members
Scrubs provided to ensure a professional and comfortable work environment
Opportunities for promotional growth as we continue to expand our presence
Monthly bonus based on your performance and productivity
Annual License renewal reimbursement

Fulltime

Multi-Site Manager

WellNow Urgent Care’s Multi-Site Manager position is responsible for leading two...

Location

United States of America , Frankfort

Salary:

60000.00 USD / Year

WellNow Urgent Care

Expiration Date

Until further notice

Requirements

3+ years of experience in healthcare environment and clinical experience preferred
Ability to work both independently and in a team environment
Strong interpersonal and communication skills and the ability to work effectively with a wide range of people
Skill in organizing and establishing priorities
Must be detail-oriented and well organized
Microsoft Office experience
Must have reliable transportation
Ability to work flexible schedule including evenings and weekends
Travel required – approximately 50%
Effective communication and interaction with employers, patients, providers, managers and other colleagues

Job Responsibility

Monitors Practice Metrics
including patient satisfaction, patient visits and expenditures
identifies opportunities for improvement and executes improvement plans approved by Leadership
Ensure patients, visitors, medical staff, colleagues and others are treated with compassion and respect
Strives for excellent patient satisfaction
Places an emphasis on patient safety, quality, convenience and customer service
Supervises the orientation, training and cross training of clinic staff with the assistance of the clinical lead and provider to ensure that all competencies, policies, established practices and standards are followed and adhered to
Participates in the development and leads the execution of UC goals and objectives
Clearly communicates goals and objectives to employees in partnership with the clinical lead and provider
Responsible for employee timekeeping, attendance tracking, absence management, and approvals in a timely manner

What we offer

Competitive salary
Parental leave
Continuing education opportunities
Medical benefits, including vision coverage, FSA/HSA options, and prescription drug coverage
401(k) plan with a company match for your future financial security
Free urgent care visits for you and your immediate family members
Scrubs provided to ensure a professional and comfortable work environment
Opportunities for promotional growth as we continue to expand our presence
Monthly bonus based on your performance and productivity
Annual License renewal reimbursement

Fulltime

Site Monitoring Lead / Clinical Operations Lead

Parexel

Location:
Germany

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 04, 2026

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