Clinical Team Lead, Site Operations Job at iconplc (Hickory)

Team Lead, Site Operations

Team Lead, Site Operations - Hickory, NC (Onsite) ICON plc is a world-leading h...

Location

United States , Hickory

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3+ years of experience in clinical site operations, site support, or clinical operations
Prior lead or mentoring responsibilities preferred
Good understanding of clinical trial processes, GCP, and site documentation requirements
Strong leadership, communication, and organizational skills
Ability to manage multiple studies and priorities in a fast-paced environment
Collaborative, solution-oriented mindset with focus on quality and customer service
Bachelor’s degree in life sciences, healthcare, business, or a related field

Job Responsibility

Supervising a team of site operations staff (e.g., Clinical Research Coordinators, Clinical Research Nurses), overseeing daily workloads and priorities
Ensuring timely and accurate completion of site start-up, maintenance, and close-out tasks in line with SOPs and study plans
Monitoring site operations metrics and contributing to actions that improve efficiency and site experience
Collaborating with project management, monitoring, and other functions to resolve site-related issues
Supporting training, development, and performance management of team members
Contributing to the enhancement of site operations processes, tools, and documentation

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

Fulltime

Team Lead Of Site Operations (Oncology)

Piper Companies is seeking a Team Lead, Site Operations (Oncology) to oversee si...

Location

United States , Downers Grove

Salary:

80000.00 - 90000.00 USD / Year

Piper Companies

Expiration Date

Until further notice

Requirements

Experience in Oncology and Cardiometabolic clinical research
Background in clinical site operations or clinical operations
Prior leadership or mentoring experience is required
Knowledge of GCP, clinical trial processes, and site documentation
Bachelor’s degree in life sciences, healthcare, business, or related field

Job Responsibility

Supervise and support site operations staff, including Clinical Research Coordinators and Nurses
Oversee site start-up, maintenance, and close-out activities per SOPs and study plans
Monitor site metrics and support process improvements
Collaborate with cross-functional teams to resolve site-related issues
Support training, development, and performance management of team members

What we offer

Health
Vision
Dental
PTO
Paid Holiday
Sick Leave if Required by Law

Fulltime

Clinical Operations Lead

A Clinical Operations Lead is needed for a contract opportunity with our South S...

Location

United States , South San Francisco

Salary:

Not provided

Revel IT

Expiration Date

Until further notice

Requirements

At least 2 to 5 years of relevant experience
Knowledge of Drug Development and Clinical Operations or related areas
Thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational
Apply organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operations’ programs, studies, and/or enabling projects
An effective communicator that shares information transparently and strategically
comfortable working out loud and is an active listener
Ability to serve as a resource for colleagues
can work across moderate sized projects with manageable risks and resource requirements
Fast adoption, foster changes and being change agents for investigators/patients to adopt new digital technologies in conducting clinical studies
Identifies, contributes to and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives

Job Responsibility

Clinical operations – contribute in operational activities that enable trial execution and delivery of the PD portfolio of clinical studies and programs across Disease Areas by providing operational and/or strategic input to the teams
Local and global initiatives
Other responsibilities according to business needs and priorities
Promote and support quality and compliance by being accountable for gcp/gvp compliance, data integrity, and taking a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed
Ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities
Building subject matter expertise on specific clinical operations activities through supporting the execution of clinical trials and/or enabling projects across geographies
Collaborating across PDG and other functions to develop and implement best practices across clinical operations and delivery of the portfolio
Works in rapid cycles (real-time optimization) to prioritize (i.e., determine what work is essential or proposed to stop in order to create the capacity to focus on what matters) and ensure alignments of priorities to the mid- and long-term outcomes

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

Lead Clinical Site Ambassador

The Lead Clinical Site Ambassador is accountable for the strategic and operation...

Location

United States

Salary:

131000.00 - 164000.00 USD / Year

The Muse

Expiration Date

Until further notice

Requirements

At minimum, bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
A minimum of 10 years' relevant clinical research (or related) experience within the pharmaceutical industry
Previous experience in leading and managing a team of professional staff
A solid understanding of the drug development process, and specifically, each step within the clinical trial process
Experience in site management and monitoring and overseeing large and/or complex global clinical trials
Robust budget forecasting and management experience
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

Job Responsibility

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, in partnership with CROs
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
Support sites in understanding study expectations, timelines, and required deliverables
Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs
Build and maintain strong, trusted relationships with investigators and site staff - Face of CSL
Serve as the sponsor primary point of contacted for assigned studies
Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration

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

Investigator Contracts Lead - FSP (Site Contracts Lead)

Key Accountabilities: Contracting deliverables. Exercise good judgment in balanc...

Location

Australia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Knowledge of the principles, concepts and theories in applicable business discipline
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix based organization
Fluency in written and spoken English is required

Job Responsibility

Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams
Contributes to design, development and implementation of major business initiatives or special projects

Veterinary Surgeon - Team Lead

We are seeking a highly motivated and experienced Veterinary Surgeon to join our...

Location

United Kingdom , Bolton

Salary:

67240.00 GBP / Year

Animal Trust

Expiration Date

Until further notice

Requirements

MRCVS/FRCVS
VetGDP accredited
Clinical experience in veterinary practice, with a strong foundation in mentoring and developing others
Excellent communication, leadership, and organisational skills, with a passion for developing and supporting newly qualified clinicians
Previous experience in training and mentoring new graduates is desirable but not essential
An appreciation of the applications of clinical governance to maintaining standards of care

Job Responsibility

Oversee the clinical development and training of new graduate and <3yr qualified vets on site
Serve as a VetGDP (Graduate Development Programme) Advisor, supporting recent graduates through their training
Collaborate with the Lead Vet to identify and address training gaps within the team
Support the Lead Vet and Clinical Operations Lead with the delivery of training sessions and clinical development programs
Line manage and mentor on site recent graduates (those on the foundation pay scale), providing them with ongoing guidance, feedback, and support
In the absence of a Lead Vet, collaborate with the Practice Manager and Clinical Operations Lead to line manage experienced veterinary surgeons
Assist with setting performance goals, conducting appraisals and supporting career development for the veterinary team
Assist Practice Manager and Lead Vet in maintaining and improving clinical standards within the clinical team
Assist Lead Vet and Practice Manager with clinical audit activity
Contribute to clinical governance initiatives by reviewing clinical performance of direct reports, ensuring training and compliance in line with company protocol

What we offer

6 weeks holiday, including bank holidays
Visa Sponsorship available
CPD and Certificate funding available
Private Health Care
52 Weeks sickness benefit and free Employee assistance program — awarded after qualifying period
Enhanced maternity and paternity package
Contributory pension scheme
RCVS and VDS fees paid
Access to counselling support including mental health, financial and life counselling after 12 months of service
Cycle to work scheme

Fulltime

Manager, Clinical Operations

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

Location

United States , Raleigh; Charlotte; Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/ BA Degree is required
5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials
2-3+ years leading aspects of global clinical trials
Experience working with a CRO
Strong regulatory knowledge, including Good Clinical Practices (GCPs)
Strong decision-making, analytical and financial management skills are essential to this position
Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
Experience in leading without authority and in multifunctional matrixed and global environments
Experience mentoring/ coaching others
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability

Job Responsibility

Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge
Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
Provide input into global subject/patient recruitment plans
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight
Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc
Create and update critical trial-specific documents (for example country specific ICF) and plans
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders including, but not limited to

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

Fulltime

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Clinical Team Lead, Site Operations

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