Opportunities at IQVIA

As an Associate Clinical Project Management Director, you will manage cross functional teams across our global organization. You will be supported by domain experts in every function and enabled by best-in-class technology and data analytics. Key collaborators are the Clinical Lead for site management, the Project Management Analyst for project coordination, tracking and financial analysis and the Site Activation Manager an expert in start-up. IQVIA’s size and global footprint will present you with the breadth of opportunities necessary to develop your career.

The dedicated Immunology and Women's Health unit sits within IQVIA’s global Project Leadership organization; as a member of this group, you will be responsible for delivery of global and/or regional studies and / or critical process and vendor management in a variety of indications. Our Immunology and Women's Health team is growing quickly, and candidates with experience in the following experience can expect to have a strong impact:
 

• Autoimmune and Rheumatology (Lupus, Rheumatoid Arthritis, Osteoarthritis)
• Dermatology (Psoriasis, Atopic Dermatitis or Urticaria)
• Rare Diseases
• Plasma Derived Therapies
• Women’s Health (Fertility; Contraception; Endometriosis or Osteoporosis)

You will need to be comfortable collaborating and communicating with a variety of colleagues and clients and demonstrate flexible and creative leadership. Global experience and a biopharmaceutical, CRO or related vendor (IP supply, clinical laboratory, etc.) is ideal.

While project assignments vary, your typical responsibilities might include:

• Serving as the primary project contact with the client
• Leading and managing cross-functional project teams
• Project status reporting and surveillance for risk
• Monitoring team performance against contract and client expectations and according to key performance metrics
• Leading problem solving including management of risk and issue resolution
• Developing or reviewing study management plans
• Managing team resource assignments and accountability
• Oversight of database management
• Ensuring compliance with study tools, training materials and standard processes, policies and procedures.

Minimum Required Education And Experience

• Bachelor's degree in life sciences or related field and 10 years’ clinical research experience including 6 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.

Physical Requirements

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

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About the job

Responsibilities

• Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global)
• Provide leadership and senior support to DTLs on multiple large global programs of global studies
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources
• Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Independently manage SOW/budget
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

Required Knowledge, Skills And Abilities

• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent organizational and problem-solving skills
• Excellent project management skills
• Ability to work independently
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with co-workers, managers and customers

Minimum Required Education And Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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Job Overview:
You will manage, develop and grow a team of Statistical Programmers through coaching, mentoring and providing opportunities through challenging assignments. You will help to shape and implement new procedures and training programs while also leading projects to deliver solutions to internal and external clients.

Your daily missions would include:

• Technical responsibilities:

1. Serve as a Statistical Programming consultant for the department and other Biostatistics departments within the company.
2. Maintain knowledge and awareness of developments in statistical programming.
3. May participate as high level lead Statistical Programmer on major project(s).
4. Provide advanced technical expertise for internal and external clients.
5. Independently bring project solutions to the Statistical Programming department
6. Provide expert review of process and methodology development work with regard to SP standards and validation procedures

• Manage staff in accordance with organization’s policies and applicable regulations.
• Coordinate and participate departmental and cross-functional process improvements
• Assist with sales meetings, proposal preparation and proposal review

Our perfect candidate needs the following:

• Master's Degree in Computer science or related field and 5 years relevant experience including 1 year in a leadership capacity or Bachelor's Degree in Computer science or related field and 6 years relevant experience including 1 year in a leadership capacity
• Advanced knowledge of SAS and technical database skills
• Knowledge of statistics and/or the clinical drug development process
• Excellent written and oral communication skills with good interpersonal skills
• Very good problem solving skills
• Excellent presentation skills
• Sound judgment/decision making
• Ability to lead and motivate a team
• Ability to effectively delegate work
• Ability to effectively motivate other staff members
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Already possess the right to work in the recruiting countries without the need for a visa/sponsorship/Blue Card etc

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About the job

IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home or office based):

Responsibilities:

• Import data from various sources
• Program quality control checks for source data and reporting data issues
• Interpret project level requirements and develop programming specifications
• Write programming code following established Good Programming Practices
• Program SDTM and ADaM datasets
• Program to create statistical analysis tables, listing and figures
• Validate datasets and all statistical outputs per prescribed gate checks
• Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
• Use and promote the use of established standards, SOPs, and standard methodologies
• Export data and clinical study report materials
• Provide training and mentoring to team members and department staff

You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.

THE PERSON

• We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.

Key required skills include:

• 3+ experience in Statistical Programmer role from CRO
• Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
• In light of the above, candidates for the roles should exhibit the following skills and competencies:
• Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
• Knowledge of statistics and exhibit routine and occasionally complex analytical skills
• A focus on quality, accuracy, and completeness of work activities
• Excellent communication skills
• A good understanding of Good Clinical Practice and ICH guidelines
• Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
• Take initiative and can be counted on to get the job done, with integrity
• Have the self-awareness to recognize when negotiating skills and assistance are needed
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients