Clinical Project Director
Warszawa
NR REF.: 1020768

CLINICAL PROJECT DIRECTOR
Reporting to: Head of Clinical Operations

1. Summary of Job Specification

Ensures the contracted clinical research projects are performed in accordance with the executed contract and budget and in line with the Sponsor’s expectations. Conducts the role of a project manager on assigned studies, which may range from single service project to large full scope or multiple protocol projects. May be assigned in the role of global project manager or program manager, as needed. Provides supervision for project managers and project teams within a specific therapeutic area or larger projects. Carries out responsibility over vendor management and proper and efficient budget and resources utilization.

2. Detailed Job Duties and Responsibilities
A. Supervises overall aspects of project management:
Acts as a main interface between company and the Sponsor to ensure study start-up, realization phase and closure are in accordance with the contract between company and the Sponsor. Ensures the study is progressing according to internal and Sponsor quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines and local laws and regulations.
Serves as a functional or project team leader; facilitates team cooperation and communication. Facilitates and coordinates internal cooperation between other departments within company for project related tasks and/or issues. Plans, manages and coaches resources engaged across all areas for projects.
Coordinates the project start-up activities with Project Managers or CRAs to ensure contracted timelines delivery.
Manages multiple projects of different size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or programs. Presents skills of independent and mature manager that requires very minimal interaction from the supervisor. Management includes but is not limited to overseeing progress on contracted services and tasks, timeliness, resources, risk, quality and communication.
Manages the executed contract and budget of assigned projects/programs. Controls and tracks the budget monthly and cumulative realization. Approves study budgets and expenses. Follows up on vendor, site and investigator payment issues as required. Ensures Sponsors are invoiced in a timely manner and payment is received.
Acquires and develops therapeutic knowledge in a project or a program field. Facilitates project team training in regards to protocol, therapeutic field and SOPs.
Reviews study documents including protocol, Case Report Forms, ICF and verify for consistency. Ensures that the sponsor’s objectives are met
Plans, develops and maintains effective communication with the Sponsor and project team (“Communication plan”) through verbal and written correspondence, project status reports, progress reports, and collects adequate documentation of such communication.
Collects information through different tools and channels and evaluates project progress. Prepares overall study status on regular basis in the time intervals agreed with the Sponsor and Senior Management.
Prepares Risk Management Plan and/or Contingency Plan, if required.
Oversees the regulatory document collection and submission process.
Development and Contracting:
Provides advice to Business Development and Contract teams regarding the operational and project management aspects of projects.
Manages negotiation and contracting process with all outside vendors supporting the project such as laboratories, drug storage, packaging companies, and Interactive Voice Response System companies etc.
Supports acquiring new and repeating business; Supports the Business Development Department by providing information on company capabilities, patient populations etc.
Presents company capabilities as well as provides project management strategy and therapeutic support at Sponsor bid defense meetings.
Cooperates with Business Development and the Proposal/Contracts groups to develop proposals for Sponsor requested opportunities. Works with those teams towards development of a budgets and a scope of work for the final contract.


3. People Management and People Supervising Responsibilities
Supervises the work of clinical research staff from the project or functional angle once assigned by Head of Clinical Operations.

4. Education / Qualifications / Skills Requirements
University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
Minimum of six (6) years of clinical research experience (including pre-study, initiation, routine monitoring and closeout visits)
Deep knowledge of GCP including good understanding of regulatory requirements


Strong presentation skills; Strong interpersonal skills as well as a team-oriented approach; Good planning, organization and problem solving abilities