Site Management and Oversight Lead Job at The Muse

Director, Regional Head Site Management & Oversight, EMEA

The Director, Regional Head Site Management & Oversight provides strategic leade...

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
12 years+ relevant clinical research experience within the pharmaceutical industry
Experience in leading and managing a professional team with strong experience in site management, monitoring and overseeing large and/or complex global clinical trials
A solid understanding of the drug development process, and specifically, each step within the clinical trial process
Robust budget forecasting and management experience
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Proven experience in overseeing vendors and CROs
Must have experience as a 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
Must have 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

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

Site and Monitoring Health Lead - Northeast US - Fsp

Candidates must be located in the Northeast US near a major airport. Job Purpose...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
Previous CRO monitoring oversight experience and experience with oversight visits required
Lead CRA experience required
Experience in all study phases of clinical research (Phase I-III)
Previous audit and regulatory inspection experience preferred
Ability to travel up to 50%
some international travel may be required
Proficient in written and spoken English required
Proficient in local language, as applicable, preferred
Fluent in multiple languages and cultural awareness preferred

Job Responsibility

Oversight of monitoring effectiveness
Implements various types of oversight encounters and activities as applicable including but not limited to site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries
ensure timely documentation of these activities is completed and file
Completes Sponsor Oversite Visit reports consistently on time and with good quality
Utilizes a risk-based approach to review critical to quality items at the site level and study level, exhibiting an 'inspection ready at all times' mentality
Creates Study Specific Oversight Plans (SSOPs) for aligned trials in scope and /or follows SSOP when conducting oversight activities
Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality
Utilizes root cause analysis to assess identified issues and provide suggested actions to Study Management/Clinical Research Organization (CRO) to mitigate risk
Supports inspection preparation and management
Collaborative relationships

Fulltime

Site and Monitoring Health Lead

The Site and Monitoring Health Lead (SMH Lead) will apply knowledge of regulatio...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
Previous CRO monitoring oversight experience and experience with oversight visits required
Lead CRA experience required
Experience in all study phases of clinical research (Phase I-III)
Previous audit and regulatory inspection experience preferred
Ability to travel up to 50%
some international travel may be required
Proficient in written and spoken English required
Proficient in local language, as applicable, preferred
Fluent in multiple languages and cultural awareness preferred

Job Responsibility

Oversight of monitoring effectiveness
Implements various types of oversight encounters and activities
Completes Sponsor Oversite Visit reports consistently on time and with good quality
Utilizes a risk-based approach to review critical to quality items at the site level and study level
Creates Study Specific Oversight Plans (SSOPs) for aligned trials in scope and /or follows SSOP when conducting oversight activities
Troubleshoots and uses alternative and innovative approaches to solve problems impacting clinical site delivery and quality
Utilizes root cause analysis to assess identified issues and provide suggested actions to Study Management/Clinical Research Organization (CRO) to mitigate risk
Supports inspection preparation and management
Works both independently and collaboratively with cross-functional teams
Builds relationships with investigators and site staff in region

Site Management Associate II

As a Site Management Associate II (SMA II) at ICON, you will support the managem...

Location

Argentina , Buenos Aires

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in health sciences or administrative programs
At least 3 years relevant experience /strong understanding of the scope of clinical trial administration
Advanced English
Leadership skills and great potential for development
Proactive, organized, tech savvy, attentive to details

Job Responsibility

TMF filing, quality, maintenance, compliance, and oversight
Lead the development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
Maintain Registries and systems as required
Support of site payment services, patient compensation services and other local payments as required
Provide reporting to support management of clinical trials
Provide support with audit and inspection readiness activities
Lead regional activities within the team and the client
Provide support to CTA managers for development and implementation of on-boarding training for new hires: Mentor new hires and entry level CTAs
Serve as SME for key CTA processes, systems and tasks
Work with CTA managers to identify continuous improvement opportunities to enhance operational efficiencies

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

Area Lead Site of Care - (Rare Disease) Mid-South

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Greenville

Salary:

147360.25 - 199369.75 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree AND 2 years of Sales and/or Account Management experience
OR Master's degree AND 4 years of Sales and/or Account Management experience
OR Bachelor's degree AND 6 years of Sales and/or Account Management experience

Job Responsibility

Maximize site of care (SOC) opportunities in accordance with product labelling, strategic imperatives, and Company policies
Provide overview of therapy and clinical procedures involved with infusion to assigned SOC customers/partners
coordinate with Medical Affairs team
Identifying gaps in existing SOC networks, developing plans to expand SOC options
Pulling through national partnership contracts at the local level
Proactive and on-going access-related education including coding and billing and conducting quarterly business reviews with SOC administrative leaders
Serve as the lead point of contact with sales, patient services and reimbursement access functions for assigned site of care (SOC) customers/partners
Evaluate, develop, monitor, measure partnerships/business plans within the designated customer/partner accounts to align with defined objectives (profit, growth, value)
Responsible for developing and growing relationships with appropriate individuals within the accounts to meet the business needs of the customer/partner through a collaborative approach
Develop and deliver business presentations/reviews to customers/partners based on mutual needs/benefits

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

GMP QA Site lead

Lead the quality assurance for clinical trial materials and companion diagnostic...

Location

Belgium , Mechelen

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's in Life Sciences, Pharmacy, or Engineering
7+ years GMP QA experience in pharma/medical device manufacturing
Proven team leadership experience (minimum 3 direct reports)
Expertise in CAPA, change control, and deviation management
Fluent in English and Dutch is mandatory (business proficiency required)

Job Responsibility

Implement and maintain QMS compliant with EU GMP, FDA, and ICH guidelines
Serve as regulatory authority for batch release decisions (IMP, CDx products)
Lead QP oversight for UK clinical trial material releases
Drive continuous improvement through risk-based quality systems
Supervise 5-8 QA specialists across pharmaceutical and CDx verticals
Own recruitment, training, and performance development for your team
Set departmental KPIs aligned with global quality objectives
Approve CAPA, change controls, and validation protocols for: Pharmaceutical manufacturing processes, CDx IVD device development and manufacturing, Equipment/utility qualification (IQ/OQ/PQ)
Lead design verification/validation for CDx products
Manage vendor qualification and audit programs

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

Training Site Lead

Ryanair are currently recruiting for a Training Site Lead to join the Engineerin...

Location

United Kingdom , Prestwick

Salary:

Not provided

Ryanair - Europe's Favourite Airline

Expiration Date

Until further notice

Requirements

Must Hold experience in Engineering Technical Training in a supervisory/management role
Must Hold 5+ years previous experience working in Aircraft Engineering
Strong organizational skills and the ability to build and deliver the most effective training programmed to meet the above-mentioned training requirements
A keen eye to detail and ability to escalate issues to the management team
Ability to plan and work to deadlines laid out by the management teams
Good working knowledge of Office 365, and keen to learn new programs/software tools to enhance working ways
Ability to scrutinize and supply constructive critique where non-compliance may be found to the management team
Be an effective communicator and interact with the team through all types of communication (verbal, face-to face, virtual)
Ability to work under pressure to meet deadlines
Ability to seek and find solutions and address them to the management team

Job Responsibility

Support the training manager in managing all engineering training requirements in Ireland/UK
Ensuring all Technical Training is prepared and delivered in compliance with EASA Part-145 and EASA Part-147 regulations, where applicable
Provide oversight, liaison, and support of trainees
Management of the local training records and communicate all training expiries to the management teams
Fully able to maintain and develop the local training Centre for further learning enhancements across all levels of training
Develop instructor materials (course outlines, lesson plans, background material, instructional materials, and training aids) at the request of the training manager
Strong capability to demonstrate a 'hands on' attitude
Strong organisational skills and the ability to build and deliver effective training programmed to meet the above-mentioned training requirements
Clear communication (written & oral) and presentation skills

What we offer

Competitive salary
Discounted and unlimited travel to over 250 destinations
Defined Contribution Pension Scheme – Matched up to 5% or €5,000
Death in Service Benefit – Up to 2 times of annual basic salary
20 Days Annual Leave – Increasing to 22 days after 12 months and 25 days after 3 years of continuous service
Option for up to 5 additional unpaid leave days per year
Cycle 2 Work Scheme
Unrivalled career progression

Regional Project Management Lead

Lead, mentor, and develop a team of construction project managers, fostering a c...

Location

United States , Charlotte; Tallahassee; Fort Lauderdale

Salary:

120000.00 - 140000.00 USD / Year

JLL

Expiration Date

Until further notice

Requirements

Lead, mentor, and develop a team of construction project managers
Conduct regular performance reviews, provide feedback, and identify development opportunities for team members
Ensure project managers are aligned with organizational and client goals
Provide oversight and guidance on project planning, budgeting, scheduling, execution, and closeout processes
Ensure projects are delivered on time, within budget, and to required quality standards
Review and approve project plans, budgets, schedules, and change orders
Optimize allocation of resources across projects
Coordinate with other departments and external stakeholders to ensure resource availability
Oversee yearly project creation, budgeting and scheduling of the client's Capital Plan by the IFM team
Examine/evaluate team's project budgets and financial performance

What we offer

401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Early access to earned wages through Daily Pay

Fulltime

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Site Management and Oversight Lead

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