Department: Investigator Contract Management (ICM)
Reports To: Director, Clinical Business Operations, (Investigator Contract Management)
Education Required: BA/BS with 4 years’ experience or up to 8 or more years in clinical operations preferably within the biotechnology, pharmaceutical, CRO, industry.
- The Contract & Budget Manager will undertake activities to provide specialized support and manage the investigator contract lifecycle process and manage staff within the well as support other Departments, as required, which are involved in the planning, execution, management Investigator Contract Management Office as and tracking of global clinical trials which may be subcontracted to an external service provider
- The key duties and responsibilities associated with this position include but are not limited to the following: clinical trial program/study budgets (developing, planning, negotiating, tracking and administration); assisting in the review and negotiation of proposals from partners; assisting in preparation, review and negotiation of budgets with investigative sites or service providers; serve as the first escalation point for Clinical, Legal, Sites and/or external service provider in accordance with the stated timeline to meet the business objectives.
Essential Functions of the job:
- Lead the contract and budget team through the contract management lifecycle process for all phase clinical phase trials.
- Partner with external CROs to ensure that BeiGene policies/guidelines are being adhered to as external partners negotiate with potential sites to become participants in trials;
- Provide oversight to external partners to ensure the contract lifecycle is being managed per BG best practices and guidelines;
- Ensure all investigator contracts are reviewed and approved by legal prior to execution;
- Issue and track confidentiality(CDAs), if required;
- Prepare program/study status reports for management
- Attend/participate in operational study/program meetings, as needed;
- Review, negotiate and approve the terms and conditions for complexed contracts in accordance with internal policy and applicable laws;
- Develop and approve investigator site and baseline budget;
- Manage the process of subsequent contract amendments, note to files and other contract related requests;
- Assist colleagues with the resolution of problems related to contract terms and conditions, compliance with sponsor and institutional policy, and any other contract related issues;
- Lead active/frequent communication with external partners and/or investigators and internal departments regarding research contracts throughout the contract lifecycle;
- Provide training to new ICM team members, as applicable;
- Manage the electronic records and documentation process;
- Maintain and distribute reports to internal and external partners for updates on status of assigned contracts and other activities;
- Develop ICM process improvement guidelines;
- Oversee the setup of ICM SharePoint work environment
Manage and mentor ICM associates and other staff as needed
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.
Proficiency in the Microsoft Office Suite, Outlook, Word, Excel, SharePoint and Grants Manager or similar system
- Prior global site contract and budget negotiation;
- Ability to negotiate basic and complex contract and payment terms;
- Strong interpersonal skills and professional attitude cross functionally;
- Goal and task oriented, self-starter with proven ability to work functionally;
- Able to proactively identify issues and provide potential solutions for resolutions;
- Detail Oriented;
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated.
Travel: Estimated 1-4 times a year