Manage the operational aspects of projects to support right subjects and right data to meet or contractual requirements.
Collaborate with project leader and LCA to establish an integrated set of plans with Clinical Lead (CL) to be ultimately accountable for results of the clinical team.
Represent clinical delivery with customer.
Produce and distribute status, tracking and financial reports for the core project team, other functional groups and senior management.
Responsible for tracking financial deliverables, reporting and invoicing on projects.
Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer.
Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points.
Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues.
Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress.
Report progress to appropriate clinical management and project management forums.
Accountable for approving final sites lists.
Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Leader.
Collaborate with other functional groups such as Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilence, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
Provide ongoing training and support to the clinical team. Conduct frequent team meetings and ensure regular communication.
Drive high performance and efficiency of the clinical team through CRA project objectives, the conduct of monitoring visits.
Provide performance feedback to management on clinical team members.
Utilize appropriate clinical tools, processes and GDN for the study team to support the execution of clinical deliverable and study timelines.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
Proven ability to understand customer needs and appropriately influence decision making
Effective mentoring and training skills
Ability to balance operational and strategic priorities
Strong communication and interpersonal skills, including good command of English language
Effective presentation skills
Demonstrated proficiency in using systems and technology to achieve work objectives
Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline with 5 years clinical research / monitoring experience;
or equivalent combination of education, training and experience.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel requirement