Associate Start Up Project Manager
Covance
Athens, Greece
πριν από 3 μέρες

Job Overview

The Associate Local Start Up Project Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-

up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a must.

This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management.

The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.

The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally .

Responsibilities :

Assignment of site numbers

Identification of patients documents required for translation

Assessment of local sourcing availability of drug

Start-up timelines estimation

Oversight and coordination of CTC tasks during validation (support)

Coordination of collection of site documents required for EC / HA submission

Local ICF adaptation

Review and adaptation of patient recruitment and retention materials

Recruitment materials

Cooperation and support of contract / financial team during contracting process

Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status

Local IMP, drug and non-clinical supplies management

Coordination of preparation of ITFB

Education / Qualifications

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

In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered

Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

Thorough understanding of the drug development process

Fluent in local office language and in English, both written and verbal

Experience

Good organizational and time management skills

  • Working knowledge of ICH, FDA, local regulatory requirements, IRB / IEC and other applicable regulations / guidelines; familiarity with investigator start up documents;
  • previous interaction with operational project team and investigative sites preferred.

    Excellent communication skills, oral and written.

    Self-motivation with the ability to work under pressure to meet deadlines

    Works well independently as well as in team environment.

    Detail and process oriented

    Positive attitude and approach

    Interact with internal and external customers with high degree of professionalism and discretion

    Multi-tasking capability.

    Good computer skills with good working knowledge of a range of computer packages

    Ability to lead and develop junior staff

    Flexible and adaptable to a developing work environment

    Significant clinical research experience

    Job Number 2018-22094

    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.

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