Senior Clinical Project Manager, TDU

Durham (County)
04 Nov 2020
04 Dec 2020
Job Function
Project Manager
Contract Type
Full Time

The role is for a Sponsor dedicated project leadership unit in various Therapeutics Areas (Rare Diseases, Vaccines, Plasma Derived Therapies, CNS, GI, Marketed products)  and 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 TDU team is growing quickly, and candidates with experience in the following areas can expect to have a strong impact:

  • Rare Diseases (Hematology, Von Willebrand's, Allergy/Immunology)
  • Plasma derived Therapies
  • GI Inflammatory Bowl diseases, Celiac)
  • CNS (ADHD, Epilepsy, Sleep disorders, Neuropathies)
  • Vaccine
  • Gene Therapy

Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.Manages the delivery of clinical research studies from initiation to closeout.Ensures that quality deliverables are presented on time and within budget; coordinates workstreams and cross-functional project teams while monitoring the use of consistent tools and methodologies; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.Essential Functions

  • Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for, multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalise the agreed upon approach.
  • Develop integrated study management plans with the core project team.
  • Accountable for the strategic planning and execution of clinical studies as per the 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 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.
  • Responsible for delivery and management of medium to large sized, multiple and full service, multi regional studies.
  • Manage 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 contact with customer and own relationship with the project’s key customer contact(s)
  • Communicate/collaborate with IQVIA business development representatives as necessary.
  • Build the cross-functional project team 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.;
  • Ensure the financial success of the project.
  • Forecast and identify opportunities to accelerate activities to bring revenue forward.
  • Identify changes in scope and manage change control process, 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 of 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.ExperienceRequires greater than 7 years clinical research experience including 4 years project management experience or equivalent combination of education, training and experience.Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.;  Skills

  • 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.
  • Communication - 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.;
  • 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.;
  • Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
  • 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 coworkers, 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, Ownership).