About Nexinfo
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors.
We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Our ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.
Job Title: Senior Clinical Program Manager
Location: San Francisco, CA, USA
Type: Contract
The Opportunity:
This is a unique opportunity for a Clinical Operations Professional. As a Sr. Clinical Program Manager, you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management
Responsibilities:
Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (Google Cloud Platform) 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 statissues, 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.
Experience in Oncology Trials
Strong working knowledge of FDA Regulations, ICH Guidelines, and Google Cloud Platform.
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.
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.
Thanks and Regards,
Joseph
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