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Job Details

COVANCE ITALY - is looking for Clinical Team Lead with PM background.

Company: Covance
Location: Regional, Italy
Reference: 53361BR
Closing Date: 14 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

COVANCE ITALY - is looking for Clinical Team Lead with PM background. This role is only for Milan candidates with home based option, more details at http://jobsearch.covance.com/jobs/1461434-Clinical-Team-Lead-ad-.aspx

Requirements:

Clinical Team Lead - office based in Milan

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.

This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

CoSource, our insourcing division provides you with the opportunity to work directly for our clients. For these roles you will either work out of our client offices or field based – and see clinical trials from the clients' perspective. We work in partnership with global and smaller pharmaceutical companies and can support you in your career development.

About the Job

The CTL is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and ensures that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving). CTL collaborates with the local Medical Advisors to identify potential investigators and takes an active role in the completion of the site selection visits.

Responsibilities includes but not limited to:

Study Set up:
- Organizes kick-off meeting with monitoring team (MTs)
- Organizes training of monitoring teams (study procedures, study devices, monitoring plan, etc)
- Organizes investigators meetings (local, cluster or regional) as applicable
- Provides support to MTs (protocol, monitoring plan, CRF, tools etc.)
- Arranges the preparation of protocols, written subject information, CTA and other essential documents for studies initiated locally
- Prepares/supervises the preparation of local study AED within/across the country/cluster/ regions, and ensures optimization of costs
- Prepares basic documents for initial submission process and to answer clarifications/requests from ECs/IRBs/HA
- Ensures the implementation of IT systems in the countries (IVRS, eCRF,ePortal, etc.)
- Ensures compliance and consistency of clinical trial CTMS systems.
- Ensures adequate provisioning of IMP (Investigational Medicinal Product), and non-IMP, devices and materials in the country/cluster/ regions
- Participates in the revision/preparation of study progress tools
- Defines with the MT planning of sites and patients breakdown

Execution
- Coordinates and oversees field monitoring activities through regular contacts with MT, review of MVRs, checks on monitoring tool compliance
- Identifies potential problems and ensures issues are solved with action plans in place (recruitment, study conduct/data quality…)
- Ensures committed targets and timelines are met (recruitment, active/inactive sites, deadlines)
- Ensures high quality level in data collection and queries resolution for the country/region/cluster
- Oversees the Pharmacovigilance activity management
- Oversees the IPs/related material management
- Prepares basic documents for the amendment submission process and to answer clarifications/requests from ECs/IRBs/Has
- Ensures continuous budget review, through monthly progresses of the local CRO costs, patients costs accruals and any other cost as applicable Medical Affairs
- Ensures preparation and proper response to audit/inspection reports and implementation of recommendations
- Shares lessons learned and ensures adequate deployment of possible identified action plans for improvement within/across the country/cluster/region
- Oversees training activities and ensures training in case of need (i.e. protocol amendment, MP updates…)

Monitor and Control, study closure:
- Ensures the DB lock is performed according to timelines
- Ensures closure visits are done according to timelines
- Ensures the statistical analysis is performed according to timelines and supports the finalization of the Clinical Study Report for local studies
- Oversees archiving process
- Ensures that the clinical study results are reported according to the company procedures and local regulations

About You

- You should typically be qualified to degree level or equivalent in one of the life sciences
- Have worked as a SCRA/LCRA/PM within a CRO or Pharma company
- Ability to demonstrate comprehensive understanding of: ICH/GCP guidelines, Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs, Site monitoring and study site management requirements, Applicable regional regulatory requirements, Trip report review, risk planning, study plan development, resource planning and data management oversight.
- Ability to train, lead and develop junior staff.
- Ability to understand and work with financial information.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Be client focused
- Demonstrated ability to work with minimal supervision.
- Demonstrated good planning and organization skills.
- Happy to work to tight deadlines

Covance's ongoing success offers team members unsurpassed growth and career development opportunities.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time to join us!

Interested candidates have to transmit their personal cv according to the Italian legislative decree n° 196/2003

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.
- In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research Experience in pharmaceutical, 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.

Experience

Minimum of five (5) years of relevant clinical research Experience with an ability to demonstrate comprehensive understanding of:
- ICH/GCP guidelines;
- Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
- Site monitoring and study site management requirements;
- Applicable regional regulatory requirements;
- Trip report review, risk planning, study plan development, resource planning and data management oversight.
- In lieu of the above requirements, candidates with > two (2) years supervisory Experience in a health care setting and four (4) years clinical research Experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
- Additional requirements include:
- Demonstrated ability to work with minimal supervision.
- Demonstrated good planning and organization skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Demonstrated effective and professional verbal and written communication skills.
- Ability to train, lead and develop junior staff.
- Ability to understand and work with financial information.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Ability to work collaboratively within a project team.
- Ability to work efficiently and effectively in a matrix environment.

EEO Employer 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.

Regional, ITA

Regional, Italy 

Apply for this job: COVANCE ITALY - is looking for Clinical Team Lead with PM background.

Contact Information:

Address:  Covance- Brussels


Belgium
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