Senior Clinical Program Manager, Clinical Operations

Bayside Solutions; California (MO); On-site; USD 176,800 - 197,600; Full time

Job summary

A clinical research organization seeks a Senior Clinical Program Manager to lead clinical trials and ensure compliance with regulatory guidelines. This role involves managing project timelines and budgets, collaborating across teams, and analyzing data health metrics. Ideal candidates will have a degree in biological sciences and at least 8 years of experience in clinical operations, along with strong leadership and project management skills.

Qualifications

• 8+ years direct Clinical Operations experience in pharma/biotech.
• Strong working knowledge of FDA Regulations, ICH Guidelines, GCP.
• Experience in selection of CROs/vendors and management of external resources.

Responsibilities

• Manage all aspects of clinical trials within timelines and budgets.
• Analyze data health metrics to communicate with stakeholders.
• Supervise project teams and ensure goals are met.

Skills

Clinical Operations

Project Management

Risk Management

Stakeholder Management

Data Analysis

Team Leadership

Budget Management

Education

RN or Bachelor's/Master's in biological sciences

Tools

Microsoft Office Suite

MS Project

Smartsheet

Job description

Senior Clinical Program Manager, Clinical Operations

Base pay range

$85.00/hr - $95.00/hr

Salary Range

$176,800 - $197,600 per year

Location

Redwood City, CA - Onsite Role

Job Summary

This is a unique opportunity for a Clinical Operations professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of clinical trials.

Duties and Responsibilities

• 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 contributes 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.


• Participate in other Clinical Operations activities as appropriate.


• 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. Coaches direct report(s) on their performance, development, and career interests.

Requirements and Qualifications

• RN or Bachelor's or Masters degree in biological sciences or health-related field required.


• 8+ years (CPM) or 10+ years (Sr. CPM) 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 4 years (CPM) or minimum of 6 years (Sr. CPM) 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 Qualifications

• 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 for Sr. CPM role and mentoring experience for CPM.

Desired Skills and Experience

Clinical Operations, Clinical Program Management, Clinical Trial Management, Good Clinical Practice (GCP), ICH Guidelines, FDA Regulations, Standard Operating Procedures (SOP), Cross-functional Team Leadership, Project Management, Budget Management, Timeline Management, Risk Management, Contingency Planning, Data Health Metrics Analysis, Query Resolution, Data Review, Vendor Management, CRO Management, Contract Research Organization Selection, RFP Development, Study Protocol Development, Clinical Study Documentation, Clinical Study Execution Team (CSET) Leadership, Stakeholder Management, Strategic Planning, Operational Planning, Therapeutic Area Development, Team Development, Performance Coaching, Talent Retention, Clinical Trial Start-up, Clinical Trial Close-out, Regulatory Documentation, External Resource Management, Microsoft Office Suite, MS Project, Smartsheet, eTMF, EDC, IRT, CTMS, Oncology Clinical Trials, Ex-US Clinical Operations, Pharmaceutical Industry Experience, Biotech Industry Experience, Mentoring, Direct Report Management

Other Information

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Quality Assurance, Research, and Science