Covance Clinical Research Manager - Poland - Warsaw in Warsaw, Poland

Job Overview

We are currently looking for talented Clinical Research Manager to join our team in Warsaw.

You would be working within our Flexible Solutions department dedicated to one sponsor/client.

Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? In this position you will be accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with excellent people and expand your horizons feel free to reach us.

Responsibilities:

  • Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team

  • Responsible for project management of the assigned studies: actively plans, drive and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out

  • Review Monitoring Visits Reports and raise performance issues and training needs to CRA manager and/or functional vendor and internal management as needed

  • Perform Quality control visits as required

  • Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and supports CRAs as protocol guide and coordinate activities across the different local country roles ensuring a strong collaboration

  • Responsible for crafting and executing a local risk management plan for assigned studies

  • Ensure compliance with CTMS, eTMF and other key systems

  • Raises as needed different challenges and issues

  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners

  • Country point of contact for programmatically outsourced trials

  • Serve local business needs as applicable in his/her country (If delegated can sign contracts and run budgets)

  • Collaborate internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies

  • As a customer-facing role, this position will build business relationships and represent the company with investigators

  • Share protocol-specific information and standard methodologies across countries\clusters

Education / Qualifications

University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution

Experience

Previous experience in clinical research in pharmaceutical or CRO industries

Deep understanding of local regulatory environment

Strong understanding of clinical trial planning, management and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time

Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery

Strong organizational skills and time management skills

Excellent interpersonal skills

Proficiency in written and spoken English and local language

Job Number 2018-21879

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.