Clinical Project Manager (Remote)

This is full-time remote, anywhere in Eastern Europe and the base salary is for $100,000 Euros.

Hiring process is 3 steps.

Essential Duties and Responsibilities:

1) Simultaneously manages one or more full-scope, multinational and/or local projects from their

start till final deliverables to Sponsor(s).

2) Manages all aspects (including financial and clinical) of multiple related projects to ensure the

overall program is aligned and directly supports the achievement of the project objectives.

3) Acts as an internal quality control check for the project.

4) Actively participates and negotiates with Sponsor(s) in establishing project-specific practices,

templates, policies, tools and partnerships to expand and mature project services and meet

Sponsors` expectations.

5) Manages and delegates project tasks and responsibilities to relevant project personnel.

6) Assists Business Development department in preparation of budget proposals and participates in

bid defense meetings.

7) Acts as the main project-specific contact person for Sponsor(s) at the project operational level.

8) Sets up project team in close cooperation with the Head of Clinical Operations, Project

Management and Human Resources departments.

9) Sets up and maintains all systems: CORE project, FLEX, CTMS, eTMF etc.

10) Coordinates and controls project teamwork, coordinates other functional leads` deliverables.

11) Selects and contracts vendors.

12) Performs project-specific training of project team members.

13) Develops project plans.

14) Reviews and adapts study documents to country-specific requirements.

15) Maintains country-specific project files.

16) Completes and maintains internal study metrics (e.g. Operational Status Report).

17) Reportsto the Financial Planning and Analysis and Accounting departmentsservices performed for

invoicing purposes.

18) Ensures correct reporting to the Accounting department of project-related pass-through expenses.

19) Manages project budget to ensure project profitability; takes corrective measures where necessary

to keep project in line with budget and profit expectations.

20) Assesses scope of work against contractual agreements and identifies changes in scope.

21) Manages any arising project-related issues and problems; develops and implements alternative

solutions to problems within study timelines, schedules, resources, budgets.

22) Tracks study progress against the agreed timelines and reports it to Sponsor(s).

23) Coordinates subcontractors involved in the project.

24) Monitors project team workload and identifies ongoing resources needs for projects.

25) Covers clinical project management (CPM role) activities and manages CRAs in small projects.

26) Develops Standard Operating Procedures (SOPs) and Work Instructions.

27) Follows applicable SOPs, Work Instructions, Policies.

Experience Requirements:

• At least 5 years of clinical trials related experience.

• At least 4 years of experience as Clinical Research Associate (CRA).

• At least 1 year of experience as Project Manager.

• A record of previous exceeding performance in similar or less senior positions within another CRO / pharmaceutical company.

• Experience in all types of monitoring visits.

• Experience with lead CRA function.

• Proficient project management skills.

• Ability to manage people.

• Ability to coordinate projects independently.

• Excellent organizational, record retention, decision making, customer service, leadership and

interpersonal skills.

• Ability to establish and meet priorities, deadlines, and objectives.

• Readiness to undertake extensive business travel.

• Focus on quality, precision, and timely delivery of results.

• Ability to be assertive and work independently without direct supervision as well as in a team

environment.

Education Requirements:

• A bachelor’s or master’s degree in sciences.

• A degree or postgraduate qualification in nursing, life sciences or medical sciences will be beneficial.

• English level is B2 and higher (upper intermediate and higher).

• Excellent verbal and written communication skills.

• Excellent knowledge of ICH GCP and national regulations related to clinical trials.

• Computer competence, at least MS Office.