Lead the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision making skills and innovative approaches to problem solving.
Proactively set project goals and tangible expectations for SPS project team members.
Oversee the execution of Start Up and / or Maintenance for assigned projects in accordance with the agreed Regulatory Start Up strategy.
May implement and maintain the Regulatory Start Up Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.
Manage the operational aspects of projects to achieve right subjects and right data to meet our contractual requirements.
May participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for less complex studies, in partnership with business development and senior project leader as needed.
Ensure collaboration across Site Management Leads, including communication with regions and countries, to successfully deliver the agreed project scope;
coach members of the team to ensure timely delivery of projects
Real Word Evidence resource request review and alignment from project award and during entire duration of the project.
Develop and maintain clinical project plans, including but not limited to i. e. Clinical operations plan, Regulatory Start Up Management Plan, etc.
to be incorporated into the integrated study management plan / project management plan.
Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach.
Effectively communicate and assess performance against these agreed objectives.
Ensure all appropriate subject / patient recruitment strategies are in place at the outset of the study to maximize subject / patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.
Ensure all processes and tools are available to maximize Site Management team’s ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject / patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment.
Throughout the study these strategies and materials should be kept under constant review and updated in response to progress on the study to ensure clear understanding by all parties (internal and external) of expectations throughout the recruitment period;
and inspire customer confidence in a clear and enforced action plan and thereby ensure successful delivery to customer satisfaction.
Monitor progress against contract and prepare / present project information proactively to all stakeholders internally and externally as required.
Deliver the project / program according to the quality management plan. Guide Site Managers / Clinical Research Associates (CRAs) and advise on critical specific study issues.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies.
Partner with functional leaders in problem solving and resolution efforts.
Achieve project quality by identifying quality risks and issues, responding to issues which impact the clinical delivery, responding to issues raised by project team members and planning / implementing appropriate corrective and preventative action plans.
Serve as clinical project contact with customer where applicable and agreed with the project leader.
Drive for high performance and efficiency of the clinical team through Site Manager / Clinical Research Associate (CRA) project objectives including the conduct of monitoring visits.
Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
Support the project leader and accountable as functional lead, in ensuring the financial success of the project.
Ensure accurate completion and maintenance of internal systems (with emphasis on Clinical Trial Management System), databases, tracking tools, timelines and project plans with project specific information.
Identify changes in scope and support project leader in completion of the change control process.
Identify lessons learned and implement best practices.
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.
May mentor and coach colleagues as required and provide technical guidance both within and outside the project. May act as Global Site Management Lead within a project.
May Conduct co-monitoring and / or assessment visits to ensure the study is being conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.
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.
Skill in understanding and executing complex study designs.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Strong written and verbal communication skills including good command of English language.
Demonstrated team leadership and mentoring skills.
Demonstrated ability to develop and deliver project and functional training.
Excellent planning, organizational and problem-solving skills.
Ability to manage competing priorities and ensure on time, high quality delivery of project tasks / responsibilities.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Next Steps :
You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.