FSP Site Budgeting and Contracting Specialist

Prague - Czech Republic

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

OBJECTIVES/PURPOSE

Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.

Support sites and study teams to achieve rapid site start up.

ACCOUNTABILITIES
Work directly with assigned sites on all site related essential document collection and review.

Partner with internal Study Startup team CROs Clinical Operations teams and TAU partners to improve overall SSU metrics and deliver processes.

Ensure standards are applied to the SSU processes across projects.

Review site essential documents for start-up including but not limited to: ICF FDF 1572 CVs etc

Promptly recognize and improve potential site activation delays and escalate to appropriate team

members.

Track all actions and communications with sites to ensure timelines are achieved for studies and

sites assigned.

Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.

Review and provide feedback to management on site performance metrics.

Ensure accuracy and completeness of the eTMF for assigned sites during start up

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise (Breadth and depth of knowledge application and complexity of technical

knowledge)

Understanding of the pharmaceutical industry (e.g. clinical development the prescription drug

distribution process etc.)

Understanding of Clinical Trial Agreements budgeting and fair market value principals

Knowledge or FDA and ICH-GCP guidelines for conducting clinical research

Leadership (Vision strategy and business alignment people management communication influencing others managing

change)

Demonstrated ability to work across functions regions and cultures

The ability to inspire motivate and drive results

Excellent communicator able to persuasively convey both ideas and data verbally and in writing

Proven skills as an effective team player who can engender credibility and confidence within and

outside the company

Ability to distil complex issues and ideas down to simple comprehensible terms

Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Decision-making and Autonomy (The capacity and authority to make organizational decisions autonomy in deci-

sion-making complexity of decisions impact of decisions problem-solving)

Broad decision-making responsibilities:

o Ability to make decisions

o Accountable for decision making for designated tasks

o Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions

o Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution

Interaction (The span and nature of ones engagement with others when performing ones job internal and external relationships)

Effectively navigates the changing external and internal environment

Takes the initiative and proactively resolves challenges with internal and external team members.
Complexity (Products managed mix of businesses internal and/or external business environment cultural considerations)

Ability to work in a global ecosystem (internal and external) with a high degree of complexity

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:
BS degree or international equivalent

2 or more years of experience in clinical research Site Start Up within a pharmaceutical company

CRO or relevant industry vendor.

Ability to explain data to facilitate decision making processes to be data driven.

Knowledge and understanding of clinical study protocols and essential documents

Strong organizational skills decision making communication and negotiation skills

Proficient in Microsoft Excel Word and PowerPoint.

Required Experience:

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionOBJECTIVES/PURPOSE Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved. Support sites and study teams to achi...