Clinical Project Director for the pivotal RELEASE trial

Clinical Project Director

PCI Biotech is seeking an experienced clinical project director for its fimaChem programme.

We are looking to strengthen our team with an operational clinical study leader that is an excellent planner, coordinator, and communicator and can balance easily between delegation and operational work. We look for passion for clinical development and extensive experience in clinical trial operation.

As a clinical project director, you will have a wide range of responsibilities. Primarily, you will be responsible for leading the clinical study team and oversee the study CRO to achieve successful execution of the global pivotal clinical RELEASE study.

Job responsibilities:

Provides project oversight and leadership for clinical deliverables:

o  Plans and leads execution of the day to day activities for the monitoring of a clinical study

o  Takes the initiative to make things happen and leads and supports the clinical team and the CRO to ensure success according to time, quality and budget parameters

o  Communicates consistently with the clinical team and the CRO providing project objectives, expectations and status updates

o  Works with the clinical team and the CRO to set priorities

o  Ensures effective communication plans are in place for the clinical team and the CRO

o  Ensures effective escalation plans are in place for the study

o  Works with the clinical team and the CRO to facilitate cross functional communication for proactive problem-solving during the study

o  Monitors the quality of clinical deliverables and addresses quality matters

o  Identifies opportunities to improve training, execution and quality control

o  Liaises with relevant staff and CRO to provide data on clinical operations performance metrics and project status metrics

o  Works with the relevant staff and CRO to identify data related matters and risks to clinical activities; develops contingency and mitigation plans to minimize risks

Quality Development:

o  Creates and maintains, in collaboration with the CRO, project specific plans, documents and tools for the study

o  Analyses data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies

o  Ensures all trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial

o  Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines

To be considered for this role you will meet the following criteria:

·   Excellent leadership, team-working and communication skills

·   A proven track record of 7+ years of Pharmaceutical/CRO experience in international clinical trial management

·   Experience as clinical study team leader in oncology therapeutic area

·   Experience in managing CROs and other external clinical study stakeholders

·   Thorough understanding of GCP/ICH requirements

Location and reporting line

The position is up to full time and will be based at the company’s headquarter in Oslo. Flexibility with regard to working hours and travel is required. The position is currently reporting to the CMO.

Remuneration

PCI Biotech offers a challenging and exciting role in one of Norway’s most innovative pharmaceutical companies. The company offers a remuneration package including base salary, performance bonus and share options.

Please send your application within 18 October 2020.