Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for an experienced Clinical Project Director to work with one of our pharmaceutical partners. This can be a home-based position, with occasional visits to the office. It is a full-time, fixed term contract initially for one year.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
- Coordination of the operational management of assigned projects in line with Company goals and medical/scientific standards.
- Communication to all stakeholders on the progress of the study.
- Manages 1-3 Clinical Trials depending on size and complexity of the trial.
- Makes appropriate operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH, GCP and Company's Standard Operating Procedures (SOPs).
- Reports to different stakeholders (like CDP team) critical steps of study conduct when requested.
- Responsible for management of the CRO, or specific activities as assigned by Disease Area Lead and/or delegated by Global CPM. Acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified. Ensures adherence to scope of work within timelines and budget. Reviews and provides input for study related documents prepared by CRO (project plan, monitoring plan, risk management plan, …).
- Prepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, blinded data reviews and any other study-relevant meeting(s).
- Ensures registration of the study in public registries (e.g: clinicaltrial.gov, European registry).
- Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator, defines CTS strategy/plan (design, quantity, sourcing strategy for comparators/Non-IMPs.); collaborates in the distribution and return strategy, participates in the follow-up/refinement of the strategy during the study conduct. Reviews the labels and leaflets; Manages the CTS once delivered to sites (accountability, temperature excursions, etc…). Approves the final destruction of CTS.
- Responsible for the management of study eTMF (related to clinical op.) and all its related activities (such as QC and health checks) with the Clinical Trial Administrator (CTA) as per Company SOP.
- Prepares the Clinical Study Report (CSR) in cooperation with the Medical Writer, reviews the CSR, coordinates its review/approval by required members.
- Act as a liaison between the Clinical Operation team and the Site Engagement Team.
Education, Experience and Skills:
- University Degree in scientific, pharmacy or other health related discipline, or equivalent.
- Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Knowledge of planning tools and planning principles.
- Knowledge of clinical research process from Phase I/II through final regulatory submission.
- Prior experience in electronic data capture preferred.
- Fluent in English and Italian.
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
- Willingness to travel.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words: Clinical Project Director, CPD, Clinical Trials, EDC, TMF, ICH-GCP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
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