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Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

We are seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role is a critical leadership role responsible for establishing, implementing, and maintaining global quality standards and processes for all company facilities and equipment. Serving as the primary point of contact and decision-maker for internal policies, procedures, and strategy documents governing the quality of facilities and equipment across the global network, this role will ensure robust and compliant infrastructure and assets. The Director will support knowledge advancement across the organization, drive process improvements and harmonization, represent the company in relevant industry forums, and partner with global quality functions to ensure consistent and high-quality standards.

Strategic Quality Oversight of Facilities and Equipment:

• Serve as the primary global point of contact and decision-maker for internal policies, procedures, and strategies governing facilities and equipment quality oversight.
• Provide strategic quality oversight for the design, installation, commissioning, qualification, and validation of facilities, equipment, and utilities, leveraging engineering standards, Quality by Design principles, and experience aligned with FDA, ICH, & ISPE guidelines.
• Ensure all activities comply with current Good Manufacturing Practices (cGMPs), company policies, and regulatory requirements.
• Sponsor and oversee process improvements and harmonization projects across the network for facilities and equipment quality.
• Ensure robust and consistent control strategies for facilities and equipment are maintained for valuation and continuous improvement, meeting regulatory and compliance expectations.
• Serve as the SME leader for facilities and equipment quality across the network, representing on relevant teams and governance forums.
• Provide technical support during new process design and facility start-up to ensure site facilities and equipment quality programs and product requirements are met.
• Provide technical support for investigations related to facilities and equipment quality to identify root causes and implement corrective actions, sharing best practices/learnings/CAPAs across the network.
• Support regulatory submissions and on-site inspections related to facilities and equipment; define and execute the process for managing network observations and commitments.
  
  

• Demonstrate in-depth understanding and application of GMP principles, concepts, best practices, and standards (US and international) specific to facilities and equipment.
• Ability to develop and improve complex concepts, techniques, standards, and new applications for facilities and equipment based on quality principles.
• Ability to develop innovative solutions to complex facilities and equipment quality problems where precedents may not exist.
• Proficiency in data analysis of facility and equipment performance, prioritization, attention to detail, critical decision-making, and complex problem-solving.
• Demonstrate extensive knowledge of industry best practices and trends in facilities and equipment quality and reliability.
• Experience building effective working relationships across all internal and external stakeholders impacting facilities and equipment quality.
• Demonstrate excellent verbal, written, and interpersonal communication skills.
• Comfortable interacting with regulatory agencies on facilities and equipment topics.
  
  

• Partner with Global Quality to support the development, implementation, and oversight of facilities and equipment quality programs.
• Ensure local and global quality decisions related to facilities and equipment are applicable, documented, and traceable to company processes.
• Support knowledge advancement beyond Quality to build and maintain capabilities across the network for facilities and equipment quality; develop knowledge-based programs and mentor stakeholder SMEs.
• Collaborate globally with engineering, facilities, manufacturing, and other departments to ensure quality requirements are met and business objectives achieved.
• Communicate effectively with senior management and stakeholders at all levels.
• Provide leadership, guidance, and support to team members, fostering a culture of quality and compliance.
  
  

• PhD with 8+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR
• Masters degree with 10+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR
• Bachelors degree with 12+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR
• Associates degree with 14+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment OR
• High School Degree with 16+ years of relevant experience in facilities management, engineering, quality assurance, or a related field within a regulated environment.
  
  

• Demonstrated understanding and relevant experience of scientific and engineering principles for the design, maintenance, and quality oversight of facilities and equipment in a regulated manufacturing environment.
• Experience in validation of facilities, utilities, and equipment.
• Significant experience leading global teams and/or projects/initiatives related to facilities and equipment quality.
• Experience with reliability engineering principles applied to pharmaceutical or similar manufacturing equipment.
• Experience with cell and gene therapy manufacturing and associated facility and equipment requirements.
• In-depth knowledge of specific regulations for cell and gene therapy facilities and equipment.
• Certification in a relevant area (e.g., CQE, CQA).
  
  

Job Summary

Job Description

What is the opportunity?

The Regulatory Risk Technical Solutions Testing department is seeking a dynamic and experienced analyst to help provide technical and analytical support towards US Wealth Management Operations and its broader Operations Risk department. In this role, data analysis and SQL development skills will be needed to support risk and audit related initiatives. In addition, business and systems analysis skills to evaluate, test, consult, and document artifacts associated to the yearly End User Developed Applications (EUDA) testing.

What will you do?

• Offers technical assistance to the broader Risk department during the audit season with population requests, key report testing, and system knowledge of the RBC systems.
• Performs data mining activities when needed for Internal and External Risk and Regulatory teams
• Conducts yearly testing activities to ensure supported End-User Developed Applications (ie Microsoft Access, Excel VBA, SQL Server Management Studio) are following Enterprise standards and provides guidance to strengthen design.
• Performs deep data analysis to identify trends and patterns in the data and root cause analysis to assist in the resolution of data issues
• Understands regulatory and firm risks associated with business processes, how work is processed from beginning to end, and dependencies to other areas and department(s)
• Contributes to the process re-engineering and process improvement, where applicable when testing EUDAs and consults with other technical operation teams on design standardization and best practices
• Collaborates with business partners to elicit, analyze and document requirements and develop process flow diagrams as needed to facilitate data analysis activities

What do you need to succeed?

Must-have

• Relevant college, university, or post-graduate degree in Computer Science or Business Analysis
• 5+ years' work experience in an analytical function (i.e. Business Systems Analyst, Technical Analyst) in a regulated industry
• Excellent communication - strong verbal, written and presentation skills
• Intermediate to Advanced level SQL development skills to extract data and perform various types of functions/operations to gain insight
• Proficient in development tools: SQL Server Management Studio 17 and above, Microsoft Access, Microsoft Excel - VBA functions; experience in .NET developer platform

Nice-to-have

• Series 7 or 99 or ability to obtain in 120 days
• Experience with complex, large-scale relational databases, with an aptitude to analyze and resolve complex data related issues.
• Attention to detail and ability to work independently and within a team
• medium to large size systems implementations, system integrations, and/or systems re-engineering projects

What's in it for you?

We thrive on the challenge to be our best, progressive thinking to keep growing, and working together to deliver trusted advice to help our clients thrive and communities prosper. We care about each other, reaching our potential, making a difference to our communities, and achieving success that is mutual.

• A comprehensive Total Rewards Program including bonuses and flexible benefits, competitive compensation, commissions, and stock where applicable
• Leaders who support your development through coaching and managing opportunities
• Ability to make a difference and lasting impact
• Work in a dynamic, collaborative, progressive, and high-performing team
• Flexible work/life balance options
• Opportunities to do challenging work
• Opportunities to take on progressively greater accountabilities
• Access to a variety of job opportunities across business

The good-faith expected salary range for the above position is $65,000 -$115,000 depending on factors including but not limited to the candidate's experience, skills, registration status; market conditions; and business needs. This salary range does not include other elements of total compensation, including a discretionary bonus and benefits such as a 401(k) program with company-matching contributions; health, dental, vision, life and disability insurance; and paid time-off plan. RBC's compensation philosophy and principles recognize the importance of a highly qualified global workforce and plays a critical role in attracting, engaging and retaining talent that:

• Drives RBC's high performance culture
• Enables collective achievement of our strategic goals
• Generates sustainable shareholder returns and above market shareholder value

Job Skills

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Note : Applications will be accepted until 11:59 PM on the day prior to the application deadline date above

I nclusion and Equal Opportunity Employment

At RBC, we believe an inclusive workplace that has diverse perspectives is core to our continued growth as one of the largest and most successful banks in the world. Maintaining a workplace where our employees feel supported to perform at their best, effectively collaborate, drive innovation, and grow professionally helps to bring our Purpose to life and create value for our clients and communities. RBC strives to deliver this through policies and programs intended to foster a workplace based on respect, belonging and opportunity for all.

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• Offers technical assistance to the broader Risk department during the audit season with population requests, key report testing, and system knowledge of the RBC systems.
• Performs data mining activities when needed for Internal and External Risk and Regulatory teams
• Conducts yearly testing activities to ensure supported End-User Developed Applications (ie Microsoft Access, Excel VBA, SQL Server Management Studio) are following Enterprise standards and provides guidance to strengthen design.
• Performs deep data analysis to identify trends and patterns in the data and root cause analysis to assist in the resolution of data issues
• Understands regulatory and firm risks associated with business processes, how work is processed from beginning to end, and dependencies to other areas and department(s)
• Contributes to the process re-engineering and process improvement, where applicable when testing EUDAs and consults with other technical operation teams on design standardization and best practices
• Collaborates with business partners to elicit, analyze and document requirements and develop process flow diagrams as needed to facilitate data analysis activities

• Relevant college, university, or post-graduate degree in Computer Science or Business Analysis
• 5+ years' work experience in an analytical function (i.e. Business Systems Analyst, Technical Analyst) in a regulated industry
• Excellent communication - strong verbal, written and presentation skills
• Intermediate to Advanced level SQL development skills to extract data and perform various types of functions/operations to gain insight
• Proficient in development tools: SQL Server Management Studio 17 and above, Microsoft Access, Microsoft Excel - VBA functions; experience in .NET developer platform

• Series 7 or 99 or ability to obtain in 120 days
• Experience with complex, large-scale relational databases, with an aptitude to analyze and resolve complex data related issues.
• Attention to detail and ability to work independently and within a team
• medium to large size systems implementations, system integrations, and/or systems re-engineering projects

• A comprehensive Total Rewards Program including bonuses and flexible benefits, competitive compensation, commissions, and stock where applicable
• Leaders who support your development through coaching and managing opportunities
• Ability to make a difference and lasting impact
• Work in a dynamic, collaborative, progressive, and high-performing team
• Flexible work/life balance options
• Opportunities to do challenging work
• Opportunities to take on progressively greater accountabilities
• Access to a variety of job opportunities across business

• Drives RBC's high performance culture
• Enables collective achievement of our strategic goals
• Generates sustainable shareholder returns and above market shareholder value

DTE is one of the nation’s largest diversified energy companies. Our electric and gas companies have fueled our customer’s homes and Michigan’s progress for more than a century. And as Michigan’s largest source of renewable energy, we’re creating a cleaner, healthier environment to power our future. We’re also serving communities beyond Michigan, where our affiliated businesses offer renewable energy, emission control technologies, and energy services to industries in 19 states. But we’re more than a leading energy company. and working at DTE is more than just a job. At DTE, we take great care of each other and our customers, and we use our energy to be a force for growth and prosperity in our communities. When you join us, you’ll be part of a team that welcomes, recognizes, and celebrates differences and values everyone’s health, safety, and wellbeing. Are you ready to make that kind of difference? Bring your energy to DTE. Together, we can achieve great things. Testing Required: Not Applicable Employment Sponsorship: This position is not eligible for visa sponsorship currently. Hybrid Role: This role is hybrid, with an established schedule of in-person work required at an assigned work location. Any remote work is expected to be performed from an employee’s primary residence, unless allowed (or prohibited) through the Company’s remote work guidelines. Emergency Response: Yes – Must be available to perform a primary assignment in support of DTE’s emergency response to storms or other events that impact service to our customers. Job Summary Responsible for the day-to-day management of multiple medium-to-large-sized, highly complex projects with minimal or no input/assistance from their management. Incumbents are devoted to project management on a full-time basis. Key Accountabilities Manages multiple medium to large-sized, highly complex projects to meet the business objective as identified in business cases; typically, 12 months or more in duration. Reviews and manages budgets, schedules, resources, and quality baselines to ensure timely delivery that meets stakeholders’ expectations. Directs and coordinates project team activities at various phases of the project life cycle. Manages relationships with project stakeholders to ensure attainment of business objectives and customer satisfaction. Coordinates and delivers status reporting to internal and external customers, vendors, stakeholders, and executive management Coaches and mentors less experienced Associate Project Managers, Project Managers, and Senior Project Managers. Minimum Education & Experience Requirements Project Management Institute (PMI) membership and Project Management Professional (PMP) certification, and a Bachelor’s Degree in IT-related discipline with 8 years of job-relevant experience, including 3 years as an IT project manager focusing on design and/or software development/implementation projects; or high school diploma and 12 years of experience including project management in an IT organization. Other Qualifications Proficient verbal and non-verbal, written and presentation skills; communicates clearly, with credibility and confidence. Ability to apply project planning & implementation and/or continuous improvement principles to affect tangible, positive outcomes. Deals effectively with resistance; takes positive steps to avoid the recurrence of errors through constructive critique. Ability to work in a ‘team’ and/or ‘matrixed’ structure, supporting multiple clients. Procedures & policy. Prefferred Demonstrated leadership in managing cross-functional teams, driving collaboration, and motivating others to achieve ambitious project objectives Proven ability to foster innovation, champion new ideas, and guide teams through change, identifying opportunities for process and product improvement Strong critical thinking and problem-solving skills; consistently applies sound judgment to complex project challenges and delivers effective solutions Track record of accountability and ownership, exhibiting reliability in decision-making and follow-through on commitments for successful project delivery. Executive presence with the ability to build trust and credibility at all levels, effectively representing project status and recommendations to senior leadership Advanced skills in strategic stakeholder management, building lasting relationships with executive sponsors and project partners to ensure alignment and project success. Excellent organizational and time-management abilities, prioritizing multiple initiatives in a fast-paced environment. Degree required with a technical focus (e.g., Computer Science, Engineering, Information Technology, or related field). PMP certification preferred; candidates actively pursuing PMP will be considered. Additional Information Incumbents may engage in all or some combination of the activities and accountabilities and utilize a variety of the competencies cited in this description depending upon the organization and role to which they are assigned. This description is intended to describe the general nature and level of work performed by incumbents in this job. It is not intended as an all-inclusive list of accountabilities or responsibilities, nor is it intended to limit the rights of supervisors or management representatives to assign, direct and control the work of employees under their supervision. PRIVACY NOTICE TO CALIFORNIA JOB APPLICANTS At DTE Energy, we are committed to providing an inclusive workplace where everyone feels welcome and a sense of belonging. We seek individuals with a heart for service, a passion to help our communities prosper, and ideas to help shape the future of energy. We are proud to be an equal opportunity, employer that considers all qualified applicants without regard to race, color, sex, sexual orientation, gender identity, age, religion, disability, national origin, citizenship, height, weight, genetic information, marital status, pregnancy, protected veteran status or any other status protected by applicable federal and/or state laws.

Job Overview:
Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Associate Clinical Lead Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

Essential Functions:

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
• Work strategically to realize clinical project goals including setting and developing clinical strategies.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
  Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
• Contribute to the development of the clinical delivery strategy for business proposals.
• Participate in bid defense preparations and meetings. Develop and present Clinical Operation
• Plans in partnership with Business Development and Project Leadership.
• Mentor and coach new peers as they assimilate into clinical lead roles.
• May act as departmental cross-functional liaison and/or change agent.
• May attend site visits as applicable in support of project delivery.
• May participate in, champion and adopt function and/or corporate initiatives, changes and or special project assignments.
• Travel up to 25%

Qualifications and Requirements:

• Bachelor's Degree Health care or other scientific discipline Req
• Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires consolidated knowledge of Project Management practices and terminology.
• Requires high proficiencies in using systems and technology to achieve work objectives.
• Requires good knowledge of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
• Communication - Strong written and verbal communication skills including good command of English language.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.; Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.; including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Collaboration - Ability to establish and maintain effective working.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at 

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Job Overview:
Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Associate Clinical Lead Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

Essential Functions:

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
• Work strategically to realize clinical project goals including setting and developing clinical strategies.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
  Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
• Contribute to the development of the clinical delivery strategy for business proposals.
• Participate in bid defense preparations and meetings. Develop and present Clinical Operation
• Plans in partnership with Business Development and Project Leadership.
• Mentor and coach new peers as they assimilate into clinical lead roles.
• May act as departmental cross-functional liaison and/or change agent.
• May attend site visits as applicable in support of project delivery.
• May participate in, champion and adopt function and/or corporate initiatives, changes and or special project assignments.
• Travel up to 25%

Qualifications and Requirements:

• Bachelor's Degree Health care or other scientific discipline Req
• Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires consolidated knowledge of Project Management practices and terminology.
• Requires high proficiencies in using systems and technology to achieve work objectives.
• Requires good knowledge of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
• Communication - Strong written and verbal communication skills including good command of English language.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.; Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.; including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Collaboration - Ability to establish and maintain effective working.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at 

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

Job Overview:
Associate Clinical Lead Directors are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies or a program of studies to meet contractual requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices. Associate Clinical Lead Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.

Essential Functions:

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
• Work strategically to realize clinical project goals including setting and developing clinical strategies.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
  Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
• Contribute to the development of the clinical delivery strategy for business proposals.
• Participate in bid defense preparations and meetings. Develop and present Clinical Operation
• Plans in partnership with Business Development and Project Leadership.
• Mentor and coach new peers as they assimilate into clinical lead roles.
• May act as departmental cross-functional liaison and/or change agent.
• May attend site visits as applicable in support of project delivery.
• May participate in, champion and adopt function and/or corporate initiatives, changes and or special project assignments.
• Travel up to 25%

Qualifications and Requirements:

• Bachelor's Degree Health care or other scientific discipline Req
• Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires consolidated knowledge of Project Management practices and terminology.
• Requires high proficiencies in using systems and technology to achieve work objectives.
• Requires good knowledge of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.;
• Communication - Strong written and verbal communication skills including good command of English language.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.; Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.; including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel
  and PowerPoint.
• Collaboration - Ability to establish and maintain effective working.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at 

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.