Clinical Project Manager Jobs

DalCor is a biopharmaceutical company focused on addressing cardiovascular disease, the greatest global healthcare burden. Our purpose is to deliver dalcetrapib, the first pharmacogenomic precision medicine in cardiovascular disease that specifically targets patients with the ADCY9 AA genotype. About 20% of the total population has this specific genotype. In a retrospective analysis of a previous trial these patients were identified to have a potentially improved cardiovascular outcome when treated with dalcetrapib.

Dalcetrapib is currently being evaluated in the dal-GenE-2 Phase 3 cardiovascular clinical outcomes trial aiming to reduce major adverse cardiovascular events (MACE). To date, dalcetrapib has been administered, with a good safety and tolerability profile, for more than two years to over 10,000 patients with cardiovascular diseases and risk factors such as obesity, diabetes, and hypertension.

A companion diagnostic test, developed in conjunction with Roche Molecular Systems, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment. DalCor obtained global rights to develop, manufacture and commercialize dalcetrapib under a license and collaboration agreement with Roche.

Position Summary:

The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial activities for assigned project(s). The CPM is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

• Ensure potential study risks are escalated to the attention of managers when appropriate.
• Maintain timelines and other tracking tools to ensure project targets are met.
• Review and approve some site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Provide and keep record of study, SOP, and system training.
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Identify needs for sponsor SOPs and contribute to the creation and review of new SOPs.
• Ensure all project level study documentation is filed in the TMF in accordance with company/ARO SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Provide efficient updates on trial progress to the Vice President of Clinical Operations and the Chief Medical Officer with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Ensure effective project plans are in place and operational for each trial, and work proactively with the Clinical Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Provide and implement problem-solving strategies to achieve project goals.
• Assist with medical and pharmacovigilance writing, including but not limited to protocol amendments, safety narratives, and the clinical study report (CSR).
• Organize and chair working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
• Lead sponsor study startup process and/or assist the ARO, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site identification, qualification and selection activities.
• Monitor and assist the ARO with end of study and site close out activities.
• Other duties as assigned
• Proactively manage project level operational aspects of the clinical team/academic research organization (ARO) including management of trial timeline, budget, resources and vendors.
• Train and delegate to Clinical Trial Assistants.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Effectively provide support to Clinical Site Manager(s) in the conduct of the trials
• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience: The ideal candidate will offer:

• Five or more years of clinical project management experience at a sponsor or CRO company is preferred for CPM
• Bachelors degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum
• Experience in Phase III trials
• Four or more years of clinical operations experience for CPM; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
• Therapeutic experience in cardiology (preferred)

Knowledge, Skills and Abilities:

• Strong written and verbal communication.
• Excellent time management and organizational skills.
• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and Good Clinical Practice/ICH Guidelines regarding drug development, clinical research and data management methods.
• Ability to work independently, remotely, and collaboratively with the team.
• Read, write and speak fluent English; excellent verbal and written communication skills.
• Proficiency in Microsoft 365, particularly Excel charts and graphs.

Work Environment: This is a fast-paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 20 % of work time.

T6r: The employee must be physically able to perform the essential job functions described above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Please note that the applicant must be a Canadian citizen/permanent resident or otherwise authorized to work legally in Canada through 2028.