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  • Posted: May 26, 2022
    Deadline: Not specified
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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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    Associate Clinical Project Management Director, Cardiovascular Renal Metabolic

    Job Overview
    Manage and support the operational elements and execution of studies and/or programs to ensure delivery; time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out. Work with study(ies)/program(s) teams to focus on leveraging deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers.

    Essential Functions

    • Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for large sized, multiple and full service, multiple country and/or multi regional studies. Understand project strategy and operationalise the agreed upon approach.
    • Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team.
    • Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.
    • Serve as primary project oversight and/or contact with customers and own relationship with the project’s key customer contact(s), communicate/collaborate with IQVIA business development representatives as necessary.;
    • Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
    • 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.
    • Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
    • Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team.
    • Achieve project quality by identifyingand proactively managing quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
    • May participate in executive committees as part of program leadership.
    • Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
    • Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward, implement appropriate actions to achieve.;
    • Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.
    • Identify and communicate lessons learned and best practices to promote continuous improvement.
    • Adopt corporate initiatives and changes, and serve as a change advocate when necessary.
    • Provide input to line managers on their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.

    Qualifications

    • Bachelor's Degree Life sciences or related field Req
    • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
    • Requires 10 years clinical research experience including 6 years of project management experience or equivalent combination of education, training and experience.
    • Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
    • Communication - Strong written and verbal communication skills including good command of English language Strong presentation skills. Requires strong negotiation and customer management skills.
    • Problem solving - Strong problem solving skills.
    • Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently. Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
    • Organisation - Planning, time management and prioritization skills Ability to 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.
    • Prioritisation - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
    • Quality - Attention to detail and accuracy in work.
    • Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
    • IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
    • Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
    • Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
    • Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
    • IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership).

    go to method of application »

    Senior Clinical Research Associate

    The individual will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

    Essential Functions

    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
    • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
    • Act as a mentor for clinical staff including conducting co-monitoring and training visits.
    • Collaborate and liaise with study team members for project execution support as appropriate.
    • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
    • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

    Qualifications

    • Bachelor's Degree Degree in scientific discipline or health care preferred. Req
    • Requires at least 4 years of year of on-site monitoring experience.
    • Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • 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.
    • Strong therapeutic and protocol knowledge as provided in company training.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
    • Written and verbal communication skills including good command of English language.
    • Organizational and problem-solving skills.
    • Effective time and financial management skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

    Method of Application

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