Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Cra Loan Officer - Az And Ny Only (Remote)
Recruited by Flagstar Bank 9 months ago Address , Remote $38,700 - $54,900 a year
Obrero 1 Jobs
Recruited by E&K of Kansas City, Inc. 9 months ago Address , Grandview, 64030, Mo
In-House Counsel Jobs
Recruited by Corserv Holdings Inc 9 months ago Address , Remote
Texas Roadhouse Restaurant Manager
Recruited by Texas Roadhouse 11 months ago Address Davenport, IA, United States
9-1-1 Telehealth Physician - California (Remote)
Recruited by MD Ally Technologies, Inc. 1 year ago Address , Remote
Clinical Research Associate (Cra)
Recruited by ClinSmart 1 year ago Address , Remote

Associate Cra Functional Manager

Company

BeiGene
Address , Remote
Employment type FULL_TIME
Salary $95,900 - $130,900 a year
Expires 2023-12-02
Posted at 8 months ago
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.
General Description:
The Associate CRA Functional Manager is responsible to complete the requirements of the BeiGene CRA Functional Manager Training Program (~12 weeks) prior to assignment of any direct reports. The Associate CRA Functional Manager training program consists of instructor led training sessions, independent learning, and task observations. After successful completion of the training program, the Associate CRA Functional Manager will assume CRA oversight responsibilities.
The Associate CRA Functional Manager will provide resourcing, oversight, study assignment, training, and metrics review for assigned CRAs, which are comprised of internal and external staff. The Associate CRA Functional Manager is also responsible for coaching, mentoring, and performance management for BeiGene staff.
The Associate CRA Functional Manager ensures proper monitoring expectations in collaboration with CTOMs; including but not limited to adherence to monitoring SOPs, ICH-GCP guidelines, country-specific regulations, and general quality and risk-based effectiveness.
The Associate CRA Functional Manager may complete assessments visits for assigned staff as required and as contracted.
Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management group as well as within the greater Americas region.
Essential Functions of the job:
The following functions may apply based on study and program requirements:
  • Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).
  • May attend, or support at Investigator meetings or Booster type visits to evaluate CRA staff.
  • Responsible for oversight of monitoring quality and metrics associated with monitoring including but not limited to trip report turn around metrics, quality of trip report, action item management, query management, data currency, and TMF management.
  • Report/escalate issues as appropriate to Clinical Operations.
  • Provide support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff
  • Assists in review of Monitoring reports to ensure quality as needed.
  • Acts as the escalation point person for CTOM(s) and study teams for CRA related issues and concerns.
  • Supports BeiGene RBx strategy and ensure engagement of direct reports.
  • Assist Learning and Development with training sessions for Clinical Operations as needed
  • Responsible for successful completion of the Associate CRA Functional Manager Training Program.
  • Responsible for performance management of BeiGene assigned staff and take remedial actions as necessary.
  • Responsible for managing relationship with CRO FSP line manager and liaising to understand and respond to feedback regarding individual direct reports or feedback about BeiGene studies or programs.
  • Functional CRA oversight for projects direct reports are assigned to.
  • Establishes regular lines of communication with CST, CTOMs and additional internal and external stakeholders to manage CRA clinical delivery
  • Working with CTOMs and Clinical Study Team (CST), manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites.
  • Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards.
  • Provide input into CRA training tools and presentations
  • Works with CTOMs to ensure adequate monitoring allocations and relevant training are correctly assigned for direct reports projects.
  • May conduct, attend, or support co-monitoring visits, as needed or as necessary to evaluate CRA staff.
  • Assists with investigator/site identification.
Supervisory Responsibilities:
  • Supervision of CRA staff
  • Assists with the identification of development opportunities for junior team members.
  • Provides necessary training to CRA staff and support site visits, as needed.
  • Co-monitoring as necessary with CRAs, if needed, to ensure oversight and address site-related concerns.
  • May supervise other roles as required within Site Management organization.
Computer Skills:
  • Familiar with industry CTMS and data management systems
  • Efficient in Microsoft Word, Excel, and Outlook
Other Qualifications:
  • Excellent organizational skills and ability to prioritize and multi-task
  • Understands clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
  • Excellent communication and interpersonal skills
  • 4+ years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
Travel:
Up to 15-25%
Education Required:
BS/BA in a relevant scientific discipline and minimum of 4+ years of relevant Clinical Operations experience, and minimum of 4+ years of monitoring experience. Experience in oncology global trials preferred.
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.
Salary Range: $95,900.00 - $130,900.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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.