Clinical Trial Manager
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.Responsibilities
The Clinical Trial Manager, Clinical Operations will be responsible for the operational management and oversight of clinical trials within a clinical development program. The position will work closely with the Medical Monitor and other cross-functional representatives including Clinical Data Management, Biostatistics, Regulatory/QA, Translational Science, Pharmacology and Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The position will lead Study Management Team (s) and also provide oversight of the CRO and other third party vendors. This individual will report into the Vice President, Clinical Operations.
- Independent management of multiple studies
- Actively provides operational direction and/or general supervision to direct reports
- Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate within Portola and/or CRO as appropriate
- Perform clinical data review of data listings and summary tables, including query generation
- Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
- Develop and maintain good working relationships with investigators and study staff
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Track and report on progress of study including site activation, patient enrollment, monitoring visits
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
- Investigate queries, monitor discrepancies
- Oversee investigational product (IP) accountability and reconciliation process
- Responsible for review or approval of IP release packages
- Negotiate and manage the budget and payments for investigative sites, if applicable
- Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
- Develop CRA and third party vendor training on protocols and practices
- 5-8 years Clinical operations experience or a combination of education and relevant work experience in the pharmaceutical industry
- Bachelor’s degree or equivalent
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Line management experience preferred
- Experience in leading industry sponsored clinical (pharmaceutical) trials
- Clinical Trial Management experience from protocol development through final study report experience a plus
- Global Phase III experience in oncology drug development desirable
- Management of international clinical studies highly preferred
- Cross-functional team leadership experience
- Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting)
- Previous experience working with an electronic data capture system and CTMS system required
- Proficient with MS Word, Excel and PowerPoint. Experience with MS Access and MS Project a plus
- Strong interpersonal, communication (written and verbal), and organizational skills
- Demonstrated ability to work independently as well as part of a multi-functional study team
- Able to motivate a team to work effectively under a changing environment
- Able to solve problems under pressure
- Self-motivated and able to work effectively in a matrix/team environment
- Availability for potential travel domestically and internationally
This job operates in a professional office environment. This role routinely uses standard office equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.
Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.