Job Description Summary:
The Contractor, Clinical Trial Site Budgets will be responsible for the end-to-end process for the clinical trial investigator grant process. This will include assisting with and oversight of the development of the clinical trial site budget template for multiple countries and producing the total study investigator grant forecast based on available protocol documents. The manager will oversee CRO site budget negotiations, including triaging difficult negotiations, as well as working directly with sites to negotiate clinical trial agreement budgets on in-house managed studies. The contractor will support the management of clinical trial site purchase orders as well as support the invoice review process, both based on the final site budgets.
The Contractor, Clinical Trial Site Budgets will work closely with cross functional teams, including Legal, Finance, Procurement, and Clinical Operations to ensure timely execution and compliance with GCP and company policies and procedures
The Contractor, Clinical Trial Site Budgets supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Provide investigator budget oversight and support. Duties include:
- Utilizing fair market value tools (ie: GrantPlan) to develop global budgets and forecasting models for clinical trials.
- Providing subject matter expertise in country level budget and negotiation strategy.
- Maintaining audit readiness for clinical trial site budgets.
- Ensuring timely resolution of escalated issues impacting site budgets or study operations. Mitigate challenges across sites for seamless site startup operations.
- Onboarding and training internal team members and external vendor partners on specific processes, reporting, and execution requirements. Coordinate site budgeting initiatives and reporting across multiple CRO partners.
Provide clinical trial site budget negotiation oversight and support. Duties include:
- Overseeing CRO negotiations for clinical trials using an outsourced startup model.
- Negotiating clinical trial site budgets directly with sites for clinical trials using an in-house model.
- Escalation and resolution of clinical trial site budgets in excess of acceptable fair market value range.
- Review site contract templates and drafts in negotiation, with focus on financial and business terms. Respond to requests from legal and interact with legal on contract templates and drafts and review budget/ SOW terms as requested by legal.
- Provide investigator payments oversight and support. Duties include auditing investigator payments to ensure timeliness and accuracy, managing late invoice payments, and providing support for Clinical operations and Finance teams.
- Overseeing clinical site purchase orders, including closely working with the procurement team to set up new suppliers, raise new purchase orders, revise existing purchase orders, and close purchase orders when needed.
Maintain and report investigator budget analytics. Duties include:
- Development and reporting of clinical trial site budget metrics, maintenance of site request escalation trackers, and development of analytics and predictive financial tools.
- Provide financial planning and forecasting of investigator grants for clinical trials and clinical projects, oversee purchase order and payment processes, develop and review quarterly financial reports with clinical leadership team.
- Collaborate with cross-functional teams (Legal, Research & Development, Clinical Operations, and Data Management) to streamline and improve processes.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
- A Bachelor’s degree and a minimum of 4 years of experience within the CRO/Pharmaceutical industry with an understanding of clinical trial processes and at least 2 years of experience working with and negotiating clinical site budgets in at least 2 continents (Americas/Europe/APAC).
* Special knowledge or skills needed and/or licenses or certificates required.
- Excellent Microsoft skills.
- Strong experience in site contract/budget negotiations.
- Ability to lead in a matrix environment.
- Strategic and creative thinker with leadership skills.
- Manage critical projects and drive multiple projects simultaneously independently.
- Experience working with cross-functional teams required.
- Must possess good organizational and interpersonal skills, as well as great attention to detail.
- Strong written and verbal communication skills.
- Excellent time management skills.
*Special knowledge or skills and/or licenses or certificates preferred.
- 5-7 years prior experience with pricing and contracts desirable.
- Experience with oncology, biologics or cell and gene therapy is preferred.
- Proficient in Microsoft Project.
* Travel requirements
#LI-NM1
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
