Contract and Budget Specialist
Kuala Lumpur, 14, MY
Job Summary
As a part of Boston Scientific's Global Clinical Contract Operations, you will develop, negotiate, and finalize Clinical Site Agreements and Budgets for medical device clinical trials in a variety of therapeutic areas by collaborating with internal key stakeholders and working with external health care institution staff. This role is a key element on the study start-up process to allow sites to participate on Boston Scientific’s Clinical Studies and ensure study enrollment.
Key Responsibilities
Preparation, negotiation, analysis, escalation, and finalization of all site agreements and budgets
- Customizes Agreement and Budget Templates: Leverages historical site data to tailor the agreement and budget templates specifically for each site, ensuring relevance and accuracy.
- Coordinates with Site for Contract Execution: Engages with site representatives to align on expectations and timelines for contract execution, aiming to meet the targeted authorization date efficiently.
- Conducts Budget Analysis and Negotiation: Reviews and analyzes the proposed budget against Fair Market Value (FMV) parameters. Utilizes historical data to negotiate site requests, ensuring consistency and fairness across site and study budgets.
Accelerate negotiations by using budget parameters
- Negotiates Site Budgets: Utilizes the fair market value established at the study’s inception to negotiate budgets with sites, ensuring financial alignment and transparency.
- Reviews and Analyzes Costs: Examines requested costs to determine their applicability to the specific phase and indication of the trial, ensuring budgetary compliance and relevance.
- Escalates Unresolved Fees: Escalates any fees that sites refuse to decrease or waive, gathering all necessary cost justifications to present to the Fair Market Value team for further review.
- Engages in Site Discussions: Participates in calls with site representatives to gain a deeper understanding of their requests, fostering clear communication and effective negotiation.
Working with legal stakeholders to negotiate contracts
- Collaborates with BSC Legal Team: Works closely with the BSC legal department to negotiate and establish mutually agreeable terms between the institution and the sponsor, ensuring all parties’ interests are adequately represented.
- Drafts and Finalizes Amendments: Develops necessary amendments for ongoing trials, coordinating with the legal team to finalize these documents for site execution during the maintenance phase, ensuring compliance and smooth operation.
- Manages Contract Concerns: Addresses and resolves contract-related issues by liaising with various divisions, effectively navigating potential standoffs and facilitating successful contract negotiations.
Maintain regular communication and escalation to expedite the planning, execution, issue resolution, and management of Site/Investigator agreements.
- Communicates Site Concerns with Trial Managers: Engages in discussions with trial managers to address and resolve any concerns raised by sites, ensuring smooth and effective trial operations.
- Highlights Contract and Budget Issues: Proactively brings any contract and budget-related concerns to the attention of trial managers as they arise during the study, facilitating timely resolution and maintaining financial integrity.
- Monitors and Supports Site Performance: Identifies sites that are not meeting established timelines and coordinates calls with the trial team to set clear goals and strategies for getting the site back on track, ensuring adherence to project schedules.
- Understand Site Activation requirements versus contracting turnaround times to support study site authorization
- Coordinates with TCRAs for Contract Timelines: Works closely with TCRAs to establish a timeline for contract execution, facilitating the planning of site authorization and enabling timely patient enrollment in critical trials.
- Routinely Reassesses Timelines with Study Team: Regularly checks in with the study team throughout the study start-up phase to reassess contract and budget timelines, identifying and navigating potential barriers to ensure adherence to target dates.
Job Qualifications:
- Bachelor’s degree, or equivalent experience
- Minimum of 1 years Industry experience managing clinical site contracts & budgets
- Demonstrates effective time management skills, including the ability to prioritize multiple tasks independently
- Demonstrates the ability to work independently and take initiative to prevent and resolve issues
- Demonstrates the ability to have strong analytical and organizational skills
- Demonstrates the ability to communicate effectively in English, both in writing and orally
- Demonstrates interpersonal skills demonstrated by being proactive, customer-focused, and independent critical thinker
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Job Segment:
Clinical Research, Medical Research, Compliance, Medical Device, Healthcare, Legal