Exel

Senior Clinical Trials Manager (Biotech Oncology)

Alameda, CA · Senior

Sponsorship not specified$172k-$245kDetected 31 days ago

GCPExcelProcess ImprovementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem Solving

About the role

This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds.
The SDL is the study accountable person, and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models.
The SDL is the Clinical Operations leader of the Study Delivery Team (SDT).

Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.
ctively partner to build relationships and collaborate with aligned staff in other functions.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary.
Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
Lead / contribute to ways of working and process improvement initiatives.
Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study.
As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members.
Work with the appropriate functions to develop patient centric documents and address patient burden.

BA/BS in biological sciences or related field and a minimum of 9 years of related experience
MA/MS in biological sciences or related field and a minimum of 7 years of related experience
PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience
Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management
Travel may be required up to 20% in support of clinical study activities
It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Experience in either starting a study up, working on the maintenance phase, or close-out of study
Protocol development experience
Proven ability to provide clinical expertise to a clinical development program.
Proficiency in clinical studies involving complex design.
Experience in independent preparation of clinical sections of IND, BLA, or NDA
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Experience with management of multinational clinical trials
Experience in interactions with outside vendors, e.g., CROs and contract labs
Demonstrated matrix leadership skills
Detailed knowledge of regulations and guidelines
Excellent organizational and planning skills
Strong interpersonal skills and communication skills (both written and oral)

The base pay range for this position is $172,000 - $245,000 annually.
The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.

The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

This listing is sourced directly from Exel's careers page and normalized into a canonical job model.