Clinical Project Manager
Job no: 613580
Work type: Fixed Term Contract (Cochlear payrolled)
Categories: Clinical Studies, Program/Project Management, Western Europe, Individual Contributor
Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Cochlear's mission is to help people Hear and Be Heard.
Our Clinical Affairs & Research EMEA department is currently looking for a Clinical Project Manager for a temporary role in our location in Basel.
The Clinical Project Manager (CPM) is responsible for the execution of one or more sponsored clinical trials in compliance with applicable SOPs, global and local regulations including European Medical Device Regulation (EU MDR), ISO14155, International Committee on Harmonization (ICH), Good Clinical Practice (GCP) and EU General Data Protection Regulation (GDPR). As the CPM, you will assist in the strategic study design, planning and execution of clinical trials while adhering to budget, scope and timelines. In addition to the execution of clinical trials, responsibilities may also include post market activities such as Controlled Market Releases (CMR) and Post Market Clinical Follow-up (PMCF).
The CPM will manage multiple aspects of clinical operations and work in close collaboration with relevant internal and external key stakeholders, to ensure high standards of clinical study execution that deliver clinical data to support the desired ethical and evidence-based claims. This role will collaborate with cross functional teams and acts as a Cochlear liaison with key industry personnel including site investigators and study coordinators and assist in the generation of clinical evidence to increase industry knowledge surrounding implantable hearing technology.
Duties and Responsibilities:
Accountability 1: Manage portfolio of Cochlear sponsored clinical investigations in EMEA
- Lead multi-disciplinary team in the conduct of a cost-effective, ethical and results focused, publishable study that supports the defined business objectives.
- Provide input and review into the development of initial Clinical Investigation Protocol (CIP) and final Clinical Investigation Report (CIR) developed by Clinical Research Program team.
- Liaise with Clinical Compliance team and Clinical Research Associates (CRA) to create and implement required study documentation and plans including the study protocol in line with local Ethics Committee (EC) and, if applicable, Competent Authority (CA) requirements, local regulatory guidelines and SOPs to ensure that all studies are conducted in a compliant manner.
- Negotiate multicentre, site specific contracts relevant to the conduct of the study including budget negotiations.
- Oversee Site Qualification, Site Initiation, Interim and Close-out Monitoring Visits to ensure Investigator Compliance.
- Manage site and subject enrolment, receipt of clinical data and reporting of adverse events to established timelines for each respective study.
- Collaborate with Data Management on study set up for paper and electronic data capture systems (EDC).
- Ensure audit-ready clinical study documentation and oversee the use of electronic trial master file (eTMF).
- Responsible for study related device accountability and tracking in collaboration with EMEA Operations and Customer Service.
- Act as primary contact between clinic trial sites and sponsor for all study specific needs including routine investigator updates.
- Create and distribute study related metrics to internal and external stakeholders including weekly and monthly updates within team, cross functional teams or senior management, and externally for clinical study sites.
- Anticipate potential obstacles to clinical study success, prepare and communicate contingency plans and implement process improvements.
- Support and contribute to papers or presentations/posters at scientific conferences based on study outcomes and align with Cochlear’s market claims.
Accountability 2: Manage portfolio of CMR/PMCF projects in EMEA
- Lead CMR and PMCF projects in compliance to internal policies and procedures as well as local market regulations.
- Develop relevant documents to plan, execute and complete the CMR/PMCF project in collaboration with relevant stakeholders: protocol, timelines, surveys, internal and external communications, training and information material, CMR/PMCF budget and for CMRs provide input in product forecast planning.
- Analyse and consolidate outcomes of CMR/PMCF data collected from internal and external stakeholders in the form of surveys and issue reports to visualize key trends and metrics.
- Coordinate training events aligned to the needs of participants in the CMR in collaboration with staff in the markets, product managers and education managers. Provide advanced product support to internal and external stakeholders during CMR with the support of Global and EMEA subject matter experts and implement knowledge transfer to Technical Support after CMR closure.
- In collaboration with Clinical Compliance team, supports definition and continuous improvement of CMR/PMCF procedures and tools to ensure these are efficient, effective for all stakeholders.
Accountability 3: Collaboration with other business units
- Occasionally support the marketing team with technical review of documentation and marketing materials.
- Stimulate the generation of new intellectual property (IP). Disseminate all relevant information within the Cochlear organization.
- MSc degree in life sciences or equivalent
- Knowledge of Medical Device Regulations on conduct of clinical studies (ISO14155, GCP, EU MDR and GDPR)
- Solid experience in data collection and analysis from human subjects
- Evidence of writing and reviewing scientific publications
- Proficiency with common business software, such as MS Office applications, electronic database systems
- Team player with the ability to work in a multi-disciplinary environment and in close relationship to clinics and research centres.
- Ability to work independently with a sense of priority
- Demonstrated organization and planning skills
- Strong interpersonal and communication skills, both verbal and written
- Excellent analytical and conceptual thinking skills with attention to detail
- Good knowledge of the English language
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age.
In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.
Advertised: Romance Daylight Time
Anticpated Application Closing: Romance Daylight Time
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