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Associate Clinical Study Manager (ACSM)

Company: BeiGene
Location: Harrisburg
Posted on: September 25, 2022

Job Description:

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.The Associate Clinical Study Manager (ACSM) leads some aspects of assigned clinical trial(s) and demonstrates a good level of knowledge of clinical operations methodologies, organizational, project management and leadership capabilities. The role works closely with the Study Manager under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery within specified quality, time and cost parameters. Works to ensure adherence to a standardized approach to clinical trial management. Reviews, tracks and files study specific documents as well as creates and updates study specific reports. Exercises discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks.Responsibilities:

  • Acts as a regional lead for large global studies, works under the guidance of the Study Manager
  • Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICFs, monitoring visits reports etc. Coordinates and tracks the distribution and retrieval of documents.
  • Assists in the set up and perform oversight of the electronic Trial Master File according to ICH-GCP, and company SOPs Ensures all documentation is in a state of audit readiness. Prepares study related documents, i.e. clinical trial tools, trackers & templates etc.
  • Coordinates with Supply Operations regarding drug forecasting and supply of study drug/comparator drug to sites
  • Performs oversight of Central Lab and other ancillary vendors during start-up, conduct, and close-out. Assists with vendor management during the coordination of Investigator Meetings.
  • Creates agendas and minutes during study team meetings under the direction of the Study Manager.
  • Performs some administrative tasks to support Clinical Operations Department and team members as needed
  • Demonstrates knowledge of sample collection, analysis process and sample reconciliation.
  • Contributes to and reviews changes in scope and change orders
  • Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical OperationsEducation Required:
    • Bachelors degree in a scientific or healthcare discipline is required; Master's degree preferredOther Qualifications:
      • 4+ years of related experience
      • Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
      • A team player and ability to take initiative and lead
      • Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
      • Proficient written and verbal communication skillsComputer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookTravel: up to 10-15%Competencies:Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: BeiGene, Harrisburg , Associate Clinical Study Manager (ACSM), Executive , Harrisburg, Pennsylvania

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