Study Guide Writer Jobs in California (NOW HIRING)

SUMMARY/JOB PURPOSE:
The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
• May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
• Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
• Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
• Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
• Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation
• Coordinates the preparation, conduct, and presentations at Investigator Meetings
• Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
• Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials
• Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
• Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines
• Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed
• Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP)
• Ensures oversight of regulatory and essential documents
• Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
• Coordinates the design, format, and content of study guides and subject instructions
• May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
• May support / be responsible for site and vendor invoice reviews
• Reviews and provides oversight of study trackers and metrics
• Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
• May be responsible for department strategic initiatives or process improvements
• May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
• BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or,
• MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or,
• PhD/PharmD in biological sciences or related field and zero or more years of related experience; or,
• Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
• Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research
Knowledge/Skills:
• Experience in either starting a study up, maintenance phase, or study close-out
• Experience with development of prospective site-selection criteria
• Protocol development experience
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
• Strong organizational and planning skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment
• Ability to understand technical, scientific, and medical information
• Demonstrated success in problem-solving
JOB COMPLEXITY:
• Ability to anticipate and resolve problems
• Ability to write and present clearly, especially on scientific and clinical issues
• Ability to work effectively in a team/matrix environment
• Demonstrated professional collaboration skills
• Understands departmental processes and implements solutions to address any task-related challenges
• Identifies and escalates issues that may have a broader impact
DESIRED BEHAVIORS:
• Ability to study, analyze and understand new situations and business problems and identify appropriate solutions
• Operationally excellent and drives others towards excellence
• Resilient in the context of a rapidly changing environment
• Works independently to meet objectives and completes tasks within established timelines.
• Organized with a systematic approach to prioritization
EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS:
• We drive for results, so patients can survive and thrive.
• We are resilient in the face of adversity, and tireless in advancing our science.
• We celebrate our long history of prolific drug discovery and rigorous drug development.
• We unite to launch innovative medicines for difficult-to-treat cancers.
• We exist to give people hope - one drug, one patient at a time.
• We are Exelixis.
LIVES THE EXELIXIS CORE VALUES DAILY:
• Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),
• Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results)
• Excel for Patients (Innovate to design solutions and remove barriers to show how much we care)
WORKING CONDITIONS:
• Travel may be required up to 20% in support of clinical study activities
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 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.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $136,000 - $192,500 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.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 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.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.