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Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
We are inspired by the potential ...
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PURPOSE
Clinical Project Management is focused on project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Focus is on leveraging deep therapeutic expertise and IQVIAs’ suite of solutions to drive operational excellence and strategic leadership with our customers. Leadership of the core project team (and/or sub-team) and responsible for achieving large, complex and multi-regional project’s overall objectives to the Sponsor’s satisfaction per Contract while optimizing speed, quality and cost of delivery and in accordance with SOPs, policies and practices.
Responsibilities
- Contribute to the development of the project delivery strategy for RFPs. Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for large, complex, multi-service, multi-region studies or programs. Understand project strategy and translate the agreed upon approach.
- Develops integrated study management plans with the core project team.
- Accountable for the execution of clinical studies per Contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against Contract and prepare/present project information proactively to all stakeholders internally and externally.
- May be responsible for delivery and management of programs of studies.
- Manage strategic risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
- Serve as primary project/program contact with Customer and own relationship with the key customer contact(s); communicate/collaborate with IQVIAs’ sales representatives as necessary.
- Drive consistency of operational delivery across customer’s projects/programs.
- Build the cross-functional project/program team and/or sub-team(s) and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
- Responsible for ensuring the financial success of project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Identify changes in scope and manage change control process as necessary; identify opportunities to increase scope to assist the Customer's business needs.
- Identify and communicate strategic lessons learned and best practices to promote continuous improvement.
- Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments; act as a client liaison, departmental cross-functional liaison and/or change agent.
- Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.
Required Knowledge, Skills And Abilities
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge; therapeutic knowledge desired
- Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Strong understanding of the competitive environment and how to communicate/demonstrate value through IQVIAs solutions
- Strong understanding of other IQVIA functions and their inter-relationship with Project Leadership
- Project management practices and terminology
- Strong understanding of, and experience managing, contractual obligations and implications
- Demonstrated strong understanding of project financials and experience managing project P&L
- Proven ability to work through others in a global environment to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback and coaching; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Ability to identify and organize resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively
- Excellent communication and presentation skills, including good command of English language
- Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
- Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it
- Excellent customer management skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall program
- Open to learning and keeping own knowledge and skill set current and evolving
- Strong software and computer skills, including MS Office applications
- Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project and taking account of a wide range of issues across, and related to, the project
- Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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; 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 regular travel.
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PURPOSE
Manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Responsibilities
Client Management:
- Serve as primary point of contact for customer on data management deliverables
- With minimal guidance, 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
- With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
- Maintain strong customer relationships
- Ensure open communications with customer and IQVIA management to manage and meet contractual obligations
Service Management:
- Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
- Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
- With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects.
- Serve as the escalation point for unresolved data issues
- With guidance, work with client data managers, vendors, internal team members for resolution
- Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
- With guidance, create and/or review and sign-off on all data management plan (DMP) documents
- Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve
- With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
- Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
- Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution
- With guidance, maintain internal tracking databases and systems
Financial Management/Business Development Support:
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
- Manage SOW/budget
- Review financial reports on a monthly basis and participate in project reviews as requested
- Identify out of scope tasks and track change orders to completion
- With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
- With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)
Other:
- Provide input on DM process improvements or project solutions to CDM team/CDM department
- Provide input on the development and implementation of a new technology or tool
- Participate in a focus team or global or local best practice team
- Perform other duties as directed by functional manager(s)
Required Knowledge, Skills And Abilities
- Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III).
- Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
- 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 applicable regulatory guidelines.
- Excellent communication, interpersonal, customer service, and teamwork skills.
- Excellent organizational and problem-solving skills.
- Excellent project management skills.
- Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs.
- 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.
- 3 years direct Data Management experience, including 1 or more years as a CDM project lead.
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About the job
Are you a freelance translator with a passion for life sciences content? Join us on an exciting journey and become a member of our growing global community of linguists. The IQVIA Translation Services team is looking for freelance translators from English into Afrikaans. You will work with a truly global industry leader to deliver content in our target languages and markets in the most effective and timely fashion. For qualified and interested candidates permanent positions may be considered as well.
In order to be considered you need to meet the below criteria:
- Native fluency in target language – spoken and written
- Fluency in source language(s) – spoken and written
- At least 1 year of experience translating, reviewing and editing life sciences content including clinical trial documents. Must be clearly outlined in your CV with document types.
- A university degree in translation or linguistics and at least 2 years of translation experience OR no university degree and at least 5 years of translation experience
- Be able to work according to tight deadlines and independently is a must
- Experience with translation management systems and CAT tools is a must
- Prior experience as a translator with a translation and localisation company is desirable, yet not essential
go to method of application »
About the job
Are you a freelance translator with a passion for life sciences content? Join us on an exciting journey and become a member of our growing global community of linguists. The IQVIA Translation Services team is looking for freelance translators from Afrikaans into English . You will work with a truly global industry leader to deliver content in our target languages and markets in the most effective and timely fashion. For qualified and interested candidates permanent positions may be considered as well.
In order to be considered you need to meet the below criteria:
- Native fluency in target language – spoken and written
- Fluency in source language(s) – spoken and written
- At least 1 year of experience translating, reviewing and editing life sciences content including clinical trial documents. Must be clearly outlined in your CV with document types.
- A university degree in translation or linguistics and at least 2 years of translation experience OR no university degree and at least 5 years of translation experience
- Be able to work according to tight deadlines and independently is a must
- Experience with translation management systems and CAT tools is a must
- Prior experience as a translator with a translation and localisation company is desirable, yet not essential
go to method of application »
About the job
Are you a freelance translator with a passion for life sciences content? Join us on an exciting journey and become a member of our growing global community of linguists. The IQVIA Translation Services team is looking for freelance translators from Zulu into English . You will work with a truly global industry leader to deliver content in our target languages and markets in the most effective and timely fashion. For qualified and interested candidates permanent positions may be considered as well.
In order to be considered you need to meet the below criteria:
- Native fluency in target language – spoken and written
- Fluency in source language(s) – spoken and written
- At least 1 year of experience translating, reviewing and editing life sciences content including clinical trial documents. Must be clearly outlined in your CV with document types.
- A university degree in translation or linguistics and at least 2 years of translation experience OR no university degree and at least 5 years of translation experience
- Be able to work according to tight deadlines and independently is a must
- Experience with translation management systems and CAT tools is a must
- Prior experience as a translator with a translation and localisation company is desirable, yet not essential
Method of Application
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