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Study Manager I

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About the role

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STUDY MANAGER I
 
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  The study manager will be responsible for the overall direction, coordination, implementation and execution of the project ensuring consistency with company strategy, commitments and goals.
 
 
Overview of the Role
  • Provide study management leadership to cross-functional teams by integrating, facilitating, coordinating and managing all activities related to the initiation, planning, execution and close out of assigned projects.
  • Responsible for managing projects to ensure integration, coordination and consistency of processes throughout the project life cycle.
  • To coordinate and manage project activities to ensure that all budgetary requirements, study timelines and targets are met.
  • To coordinate and manage the activities of individual projects in a manner that ensures that the execution of the study protocol are conducted within GCP and FDA regulations and requirements, sponsor expectations and IDS standard operating procedures. 
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Familiarize, understand and apply all IDS standard operating procedures (SOPs) applicable to job descriptions
  • Ability to understand and communicate protocol requirements to apply study management knowledge to: initiate, plan, execute, monitor/control and close clinical study
  • Obtain and review clinical statement of work (SOW) and/or study work order (SWO) to determine what services are required for each clinical trial protocol; Initiate and participate in the early planning phases of clinical study by providing guidance on deliverables and outsource options (i.e. preparation of study proposal timelines, scheduling and other study requirements as appropriate); including but not limited to study source documents, procedural timelines, lab set up, initiation of site signature log, maintenance of study enrollment log, deviation log, study status log and assist data coordinators regarding CRF’s and regulatory documents. Assure resolution of all quality control discrepancies related to data and research documents.
  • Coordinate with all study team departments to ensure adequate internal resources and resolution of any clinical study work flow issues for assigned clinical studies
  • Act as liaison and point of contact for all clinical study sponsors and vendors for IDS-SAT related services; Attend sponsor meetings and required conference calls to ensure effective communication flow between external customers and IDS-SAT; Lead and/or participate in all IDS study related meetings to include (clinical tracking, screen team, mock runs and coordinate any additional training as required by protocol).
  • Track and monitor all clinical study change requests; providing information to all appropriate internal study team members.
  • Work with IDS clinical studies unit and external vendors to discuss deliverables and timelines and communicate timelines to sponsor
  • Participate/Host Sponsor and Monitor visits
  • Identify and execute vendor contracts
  • Determine appropriate revenue recognition, ensure timely and accurate invoicing.
  • Recognize and submit out of scope requests for costing and approval.
  • Drive discussions on resolution of project issues; critically evaluate root cause and develop options for resolution and effectively communicate options for resolution to stakeholders. Understand how to communicate sensitive and difficult information tactfully.
  • Demonstrate conflict resolution capabilities, exhibit solution seeking behaviours, promote team building.
  • Monitor project metrics and project key performance indicators to ensure a high quality standard is maintained throughout the project.
  • Carry out clinical study directives from the Principal/Sub Investigator.
  • Undertake other reasonably related duties as may be assigned from time to time.
  • Inspire team members to attain goals and pursue excellence.
  • Identify opportunities for improvement and make constructive suggestions for change.
  • Manages the process of change effectively
  • Provide mentorship to Study Manager I
Role Requirements
  • To 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.
  • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
  • Excellent written and oral communication skills and interpersonal skills; Problem-solving skills;
  • Detail-oriented with excellent organizational and prioritization skills;
  • Ability to work on multiple projects simultaneously and meet varied deadlines;
  • Proficiency with Microsoft Office, Excel and Power Point
  • Self-starter with the ability to work alone and as part of a team
  • Leadership skills;
  • Demonstrated professionalism and confidence;
  • Study management skills preferred.
  • Bachelors’ degree with 5 years clinical research experience in leading and directing clinical trials. In lieu of bachelors a minimum of 8 years clinical research experience in supervising, leading and directing clinical trials.  Study Management or Clinical Research Coordinator experience preferred.
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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