Senior Manager, Clinical Operations

BeiGene

Department:  Global Clinical Operations

Reports To: Director of Clinical Operations

Education Required:

Bachelors degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience managing people is needed.

General Description:

  • Responsible for the planning, implementation and conduct of large, global, complex oncology clinical trials in Phase I-IV; or multiple smaller early-phase studies.
  • Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables.

Responsibilities:

Clinical Trial Management

  • Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision.
  • Manage CROs, vendors and consultants that are involved with the clinical trial and program.
  • Serve as the clinical operations point person managing protocol execution.
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
  • Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs as assigned.
  • Assist with training and mentoring of internal BeiGene clinical operations staff.
  • Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
  • Assist in preparation of clinical documentation for IND submissions/updates as well as NDA submission and other regulatory submissions as appropriate.
  • Oversees the review and approval of clinical monitoring visit reports and ensures that all outstanding follow-up items are closed out in a timely manner.
  • Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.
  • Manage escalation of study related issues and establish appropriate course of action with Senior Management.
  • Liaises with the clinical supply chain lead to ensure forecasting of clinical and non-clinical supplies accurately reflects protocol/trial needs.
  • Ensure that the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial.
  • Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed.
  • Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
  • Ensures quality clinical data review and data integrity for assigned clinical trial(s)
  • Leading, overseeing and participation in governance committees (eg: CST, DCT, JOC)

Fiscal and Contracts Management

  • In conjunction with legal group and/or CRO facilitate the development of clinical trial agreements and other relevant documents.
  • Review and approve site budgets, manage clinical trial budgets, liaise with finance when financial reporting and projections are requested from management.
  • Liaise with Strategic Clinical outsourcing and participate in CRO bid defense meetings and vendor selection activities to include: creation of scope of work, budgets, vendor performance and issue resolution.
  • Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance.
  • Responsible for creating program-level budget(s).

Cross Functional Mentoring and Leadership

  • Work cross-functionally to ensure clinical program timelines and goals are met.
  • Provide study-specific mentoring and line management for junior team members, as appropriate.
  • Assume leadership role in operational improvement initiatives (e.g.  SOP development, training etc.)

Supervisory Responsibilities: 

  • Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
  • Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
  • Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback

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

Other Qualifications:

  • Bachelor’s degree in health sciences or related field
  • Minimum of 5-7 years’ experience in clinical research with at least 3 years’ experience in Project Management or Clinical Monitoring preferred. Prior experience participating in a Regulatory Authority inspection strongly preferred.
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
  • Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
  • Proficient written and verbal communication skills.
  • Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Management experience of CROs, Vendors and Consultants preferred.
  • Therapeutic or medical knowledge preferred
  • Regulatory authority inspection experience a plus
  • Position will require some travel 10%-15%

To apply for this job email your details to us.careers@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook