The Opportunity: - Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
- Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.
- Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.
- Analyze data health metrics to be shared with stakeholders.
- Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process.
- Conduct risk management, contingency, and scenario planning.
- Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.
- Participate in the development of all study-related documentation, including study protocols.
- Actively contribute in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).
- Use all available tools to track, oversee, and communicate on program status to all key stakeholders.
- Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.
- Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.
- May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.
- May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation.
- Assists in the hiring, development, and retention of top talent within the team. Coach direct report(s) on their performance, development, and career interests.
- Participate in other Clinical Operations activities as appropriate.
Required Skills, Experience and Education:- RN or Bachelor's or Masters degree in biological sciences or health-related field required.
- 10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.
- Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years' experience managing project teams.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
- Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
- Experience in selection of CROs/vendors and management of external resources.
- Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
- Excellent written/verbal communication and interpersonal skills.
- High sense of priority and commitment to excellence in the successful execution of deliverables.
- Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
- Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
- Travel may be required (~25%).
Preferred Skills:- Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
- Oncology experience, early and/or late stage, strongly preferred.
- Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
- Some experience managing direct reports.
#LI-Hybrid #LI-DN1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$164,000-$205,000 USD
