We're looking for a candidate to fill this position in an exciting company.
Accountable for ensuring the right subjects and right data to meet their contractual requirements.
Participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country / region studies, in partnership with business development and senior project leader as needed.
Develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy 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 clinical 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 clinical 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 CRA's 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 to support financial success of the project.
Support the project leader in ensuring the financial success of the project.
Identify changes in scope and support project leader in completion of the change control process.
Identify and communicate lessons learned and implement 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.
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
Strong understanding of Clinical Research industry (drug / device / technology / etc.) and the relevant environments in which it operates
Ability to understand customer needs and appropriately influence decision making
Good understanding of other company functions and their inter-relationship to achieve project delivery
Knowledge of Project management practices and terminology
Ability to develop and deliver training materials to achieve clinical team understanding of project and enable effective delivery thereof
Good understanding of project financials
Proven 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 identify and organize clinical 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
Demonstrated proficiency in using systems and technology to achieve work objectives
Proven ability at analyzing data and information to derive conclusions and drive sound decision making
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 service skills and demonstrated ability to understand customer needs and appropriately influence decision making
Strong software and computer skills, including MS Office applications
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
Bachelor's degree in a health care or other scientific discipline with 7 years clinical research / monitoring experience;
or equivalent combination of education, training and experience.
At least 4 years experience in the role
At least 3 years leading clinical research studies (Regional or Global experience)
Therapeutical Area : GI
Advance english level