Manager, Clinical Operations Job at iconplc (Shanghai)

Manager, Clinical Operations

Operations Manager (LPN or RN), Bell Physician Services. Full-Time. Embracing a ...

Location

United States , Ishpeming

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

State of Michigan RN license
Associate degree from an accredited nursing school (bachelor's degree preferred)
Basic Life Support Health Care Provider (BLS-HCP)
Five (5) years in office manager (preferred)
LPN Applicants: State of Michigan LPN license
Graduated from an LPN or LVN Program

Job Responsibility

Assists with developing specific departmental goals, standards, and objectives
Manages staff relations including performance management, staff satisfaction, and conflict management
Performs and oversees scheduling, staff development, recruitment, payroll, and student engagements
Monitors departmental budgets, regulatory compliance, departmental contracts, and vendor relations
Determines and justifies needs for systems/equipment/supplies purchases
Assesses the quality of patient care delivered and coordinates patient care services with patients, staff, physicians, and other departments
May provide patient care when necessary
Creates and fosters an environment that encourages professional growth
Integrates evidence-based practices into operations and clinical protocols

What we offer

Multiple levels of medical, dental and vision coverage
Life, accident, critical illness, hospital indemnity insurance
Short- and long-term disability
Paid family leave
Paid time off
Higher education and certification tuition assistance
Loan assistance
401(k) retirement package and company match
Mental, physical, and financial wellness programs (free gym memberships, virtual care appointments, mental health services and discount programs)
Ongoing learning and career advancement opportunities

Fulltime

Manager, Clinical Operations

We are currently seeking a Manager, Clinical Operations to join our diverse and ...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or a related discipline
Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards
Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment
Proficiency in project management tools and methodologies, with a keen focus on optimizing processes
Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes

Job Responsibility

Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines
Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process
Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement
Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team
Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Parexel are currently recruiting for an experienced Global Study Operations Mana...

Location

Italy; United Kingdom , Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 7 years of relevant clinical trial management experience
Global trial management experience is essential
Experience managing CRO outsourced studies is essential
Excellent leadership, communication, and organizational skills
Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Accountable for the end-to-end clinical trial delivery
Providing operational leadership and oversight of cross-functional deliverables
Leading a cross functional trial team to build and deliver the trial operational plan
Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Associate Manager, Clinical Operations

The Manager is responsible for the oversight of a team or group. This includes e...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Substantial monitoring/data management experience or equivalent experience in clinical research with strong understanding & knowledge of clinical trials environment
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience

Job Responsibility

Monitor performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete
May be responsible for own assignments as project team member
Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget
Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables
Where assigned, produce accurate resourcing plans in conjunction with appropriate Project Team Members
Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports
Provide technical support to staff to ensure that they have the required knowledge to fulfill their duties
Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables and take appropriate remedial action
Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team
Manage and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating staff according to their ability

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...

Location

United States , Pleasanton

Salary:

173100.00 - 234100.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results

Job Responsibility

Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing and make your life easier
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

Manager Clinical Operations

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or a related discipline
Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards
Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment
Proficiency in project management tools and methodologies, with a keen focus on optimizing processes
Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes

Job Responsibility

Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines
Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process
Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement
Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team
Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Clinical Operations Manager - FSP

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience required
5‐7 years clinical research or combined experience in Clinical Research and Finance/Business required
Expertise of core clinical systems, tools, and metrics
Excellent verbal and written influencing and training/mentoring skills, in English
Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager
Ability to make decisions independently with limited oversight from SCOM or manager
Requires a strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally

Job Responsibility

Attends meetings with COMs
Data Cleaning and Consolidation: Cleaning scattered data from different systems using Python and consolidating it into a unified reporting structure
Anomaly Detection: Establishing automated alert mechanisms to identify erroneous data entries and operational risks
Automating repetitive validation checks
Develop tools to support oversight - review trends
Build dashboard to support recruitment rates, trends, study timelines, real time operational oversight
API Integration: Enabling automated data flow between systems to reduce manual data transfers
Ad-hoc Analyses: Delivering fast, data-driven customized analyses to address urgent operational needs
Documentation: Preparing technical documentation and guides for the developed tools and code structures
SME & PoC Activities: Managing pilot projects for the integration of new technologies (AI/ML) into processes and providing technical SME support to teams

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Manager, Clinical Operations

Job Description

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