Global Clinical Operations Leader / Clinical Trial Manager
Location
Worldwide
Posted
6 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Global Clinical Operations Leader / Clinical Trial Manager
Parexel
Role Description We are seeking a Global Clinical Operations Leader/Clinical Trial Manager to join our team in a remote position. As a Global Clinical Operations Leader/ Clinical Trial Manager, you will lead the clinical operations strategy and execution of global clinical trials. This role has direct accountability for delivering studies on time within budget and to the highest quality standards while ensuring patient safety and regulatory compliance. You will serve as the primary clinical liaison to project leadership and sponsor teams coordinating cross functional contributors across regions and time zones. This is a highly visible leadership role suited for individuals who thrive in complex global environments and are comfortable making decisions in ambiguous situations. Success requires strong ownership, the ability to lead without close supervision and a history of delivering clinical trials within a CRO environment. Key Responsibilities - Lead global clinical operations strategy and execution for assigned clinical trials. - Drive study startup including site selection, monitoring strategy, and operational planning. - Coordinate cross functional teams across geographies ensuring alignment on timelines, quality and deliverables. - Monitor study progress including recruitment, retention, data quality and timelines and take corrective action when needed. - Identify risks early and implement mitigation and contingency plans. - Provide leadership direction and performance feedback to project team members. - Function as primary point of contact for sponsors on clinical operations topics. - Ensure compliance with ICH GCP regulatory requirements and internal processes. - Oversee maintenance and quality of study documentation and central files. - Support audits, inspections and study closeout activities including database lock and archiving. - Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture. Qualifications - Strong leadership, decision making and problem-solving skills. - Demonstrated ability to lead global teams across cultures and time zones. - Ability to prioritize competing demands and remain accountable for outcomes. - A proactive mindset with strong ownership and sense of urgency. - Excellent communication and stakeholder management skills. - Comfort working in a fast-paced performance driven environment. Requirements - Degree in life sciences, nursing, or equivalent clinical research experience. - Minimum of 5 years of experience leading clinical operations within a CRO environment. - Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader. - Experience leading complex global or multi-region studies. - Strong knowledge of ICH GCP regulatory requirements and clinical trial processes. - Experience coordinating cross functional teams and managing study timelines, budgets and quality. - Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF. Preferred Qualifications - Prior monitoring experience or strong site engagement background. - Experience contributing to process improvements or operational excellence initiatives. - Familiarity with multiple therapeutic areas or late phase studies with priority given to those with Metabolic, Obesity, MASH, Ophthalmology and Dermatology / Immunology. Benefits The potential base pay range for this role is competitive and aligned to experience level, location and demonstrated expertise. Additional incentives may be available based on performance and role scope. This role is designed for experienced clinical leaders who are ready to take full ownership of global trial delivery. If you are looking for a position with clear accountability, high expectations and meaningful impact on patient outcomes this is the right opportunity. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Related Guides
Related Categories
Related Job Pages
More Clinical Operations Jobs
Clinical Excellence Lead
Concert HealthConcert Health is a leading behavioral health company focused on integrating high-quality mental healthcare into primary care settings through collaborative care. Founded to addres
Role Description The Clinical Excellence Lead II is an independently licensed behavioral health clinician reporting to the Clinical Excellence Manager. This role provides evidence-based interventions via the Collaborative Care Model to individuals (pediatric and/or adult populations) experiencing mild to moderate symptoms and utilizes evidence-based therapeutic interventions to promote symptom reduction and optimal patient outcomes. This position provides higher level oversight of administrative and clinical needs within the care pod(s) assigned supporting our partnership with Sutter. Administrative Responsibilities: - Indirect oversight of between 10-12 Collaborative Care Clinician’s performance including clinical metrics, schedule management, coaching, and performance management. - Responsible for supporting pod and partner workflows and needs in partnership with the Clinical Excellence Manager. - Play a lead role in new hire pod specific training including scheduling, instructing, tracking progress, troubleshooting, and supporting new staff. - Monitoring and addressing POD Admin Dashboard reports with assigned Collaborative Care Clinician. - Assist in the evaluation of employees skills and performance, provide support and additional training as requested or required. - Complete weekly chart review checklist for all assigned Collaborative Care Clinicians and communicate any areas needing improvement to the Clinical Excellence Manager. - Other job duties as assigned. Clinical Responsibilities: - Manages caseload of up to 45 patients (mild to moderate acuity) based on needs of assigned Care Pod, customizing treatment plan to individual patient needs. - Supports and closely coordinates behavioral health care with the patient’s primary care provider and (when appropriate) other service providers. - Screens and assesses patients for common behavioral health and substance use disorders using PHQ9, GAD7, Columbia Suicide Risk Assessment, or other tools as required. - Monitors patients for changes in clinical symptoms and treatment side effects/complications, with a goal of reduction in symptoms. - Supports psychotropic medication management prescribed by PCPs, focusing on treatment adherence, side effects and other complications, and treatment effectiveness. - Tracks patient follow-up and clinical outcomes using a registry, records encounters in the registry and uses the system to identify and re-engage patients. - Plans specific mutual self-management goals, objectives, and interventions with action-oriented patients. - Facilitates care plan changes for patients who are not improving, including changes in medications or psychosocial treatments or appropriate referrals for additional services. - Documents patient progress and treatment recommendations in Salesforce and the electronic health record so they can be easily shared with primary care providers, the psychiatric consultant, and other treating providers. - Completes relapse prevention plan with patients who are in remission. - Educates patients about behavioral health/substance use disorders/treatment options. - Establishes mutually agreeable care management plan with the care team and patient/family. - Participates in regularly scheduled caseload consultations with psychiatric consultants. Qualifications - Masters degree in social work, counseling, or related field. - Hold an independent license in Connecticut or be eligible to obtain independent licensure in Connecticut within 3 months. - Minimum of 2+ years of clinical experience. - Proficiency in evidence-based treatment approaches (Problem-Solving Treatment, Motivational Interviewing, Cognitive Behavioral Therapy, and Behavioral Activation). - Technical proficiency in a variety of platforms including EHRs, ability to quickly learn new technology. - Knowledge of/experience with behavioral health tools (PHQ9, GAD7, CSSRS, etc.). - Capability to provide clinical care to patients in primary care settings, including those as young as 6 years old, as well as in women's health. - One year working successfully within the CoCm model and excellent quality assurance. Preferred Qualifications - Prior experience as a Collaborative Care Clinician with Concert Health preferred. - Fluent in both English & Spanish preferred. Benefits - 100% remote with employer supplied computer equipment. - Work/life balance with 10 paid holidays, sick time, and additional PTO plans. - Medical, Dental, and Vision plans effective on the first day of employment. - Employer paid Short Term Disability and Long Term Disability plans. - Employer paid Life and AD&D insurance of $50,000. - Employer paid Parental Leave of 12 weeks. - 401K. Compensation Annualized base salary is determined by geographic location and budget and is paid on a biweekly basis: $65,000.00 - $90,863.64. Schedule Monday - Friday | 10:00am - 6:00pm Eastern Time 100% Remote Company Description Concert Health is a diverse and inclusive Equal Opportunity Employer; we prohibit discrimination and harassment of any kind in our culture. We are dedicated to providing a safe, equitable, respectful, and supportive work environment to all without regard to race, color, religion, sex, gender, national origin, age, pregnancy, disability, sexual orientation, military or veteran status, genetics, or any other status protected by federal, state, or local laws.
• Responsible for process and performance management related to the delivery of the operational function(s), as assigned. • Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. • Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM). • Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends. • Responsible for ensuring comprehensive oversight of all activities delegated to third parties. • Facilitating and monitoring CTT oversight of vendors. • Developing, reviewing and revising quality agreements with business partners. • Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations. • Facilitating and overseeing responses to audit and inspection observations as appropriate. • Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies. • Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide. • Contributing to the development and/or revision of Sponsor policies, SOPs and training materials. • Developing the strategy for management/support for GCP inspections of Sponsor products.
• Manages staff, providing coaching, mentorship and work direction. • Conducts 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. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. • Raises appropriately any issues which may impact project deliverables. • 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. May contribute to development of training programs, where appropriate. • 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. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where 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.
Part-Time Clinical Practice Manager, RN – Regional Diploma in Psychiatric Nursing Program
Stenberg CollegeOur Purpose: To Help You Find Yours
• Oversee all aspects of first-year clinical education in the Older Adult, General-Medical, and Medical-Surgical clinical practice settings • Manage clinical operations, supporting faculty and students • Maintain strong partnerships with industry partners, ensuring a high standard of clinical education • Support the recruitment, onboarding, and orientation of Clinical Practice Faculty • Provide leadership, guidance, and performance oversight to Clinical Practice Faculty and staff • Identify and address faculty development needs, oversee performance evaluations, support administrative coordination • Facilitate prep sessions for Year 1 student success in clinical practice • Ensure high-quality, compliant Year 1 clinical placements through careful site selection and documentation oversight



