Site Oversight Manager, (GCO)

  • BeiGene
  • Basel, BS, Switzerland
  • 07/04/2021
Full time Data Science Data Analytics Big Data Data Management Statistics

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:

  • Provide quality oversight to European study sites across studies (co-monitoring) to ensure appropriate study conduct and inspection readiness
  • Demonstrates a high level of clinical operations knowledge, organisational skills, project management and leadership competencies
  • Implements best practices and shares lessons learned with team and other colleagues, as appropriate
  • Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs
  • Requires significant CRA experience and understanding of site procedure
  • Perform site oversight visits to study sites and support pre-inspection visits
  • Support CRAs in preparation of audits
  • Support development of co-monitoring schedule and prioritization of sites, with input from management, study leads, regional leads, GCP compliance manager and QA, as appropriate
  • Proactively contact CRAs to schedule meetings according to co-monitoring schedule
  • Provide education, feedback and guidance to CRAs
  • Establish strong relationship with all site personnel
  • Report site or CRA issues to the study team as appropriate
  • Review investigator site files
  • Review monitoring visit schedule before a co-monitoring visit
  • Review data cleaning metrics and oversee monitoring activities
  • Facilitate issue resolution at site, including significant quality events or CAPAs, as required
  • Ensure trends and lessons learned are shared within Clinical Operations for continuous improvement of study conduct
  • Provide onboarding training and training on new processes to Monitoring Excellence and Study Management staff
  • Provide input into or lead workstreams
  • May support CSTs
  • May support or conduct feasibility, including performing Pre Study Selection Visits (PSSV) and document collection management
  • Provide input and updates into Site Intelligence Data Base

Education Required:

  • Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 3-5 years of experience in clinical operations (Manager).
  • Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 1-3 years of experience in clinical operations (Associate Manager).
    • exceptions may be made for candidates with appropriate Clinical Operations experience

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

  • Ability to work independently and effectively handle multiple priorities in a fast-paced environment
  • Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization

Travel: up to 75%

Supervisory Responsibilities:

  • Provides constructive feedback on CRAs and other team members to their line managers to support performance review

Competencies:

Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and to high ethical standards; Uphold organizational values.

Planning/Organizing – Able to prioritize and plan 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 - Synthesises 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 analyses 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, non-disqualifying physical or mental 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