We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Clinical Trials.  The Senior Manager, Clinical Trials works in Clinical Operations, managing and executing the operational aspects for clinical studies across Phase 1-4. The Senior Manager, Clinical Trials will work under the leadership of a Clinical Operations Program lead, providing leadership and driving all aspects of study execution in collaboration with cross-functional study teams and vendors for one or more clinical studies. Advance skills in clinical trial management and advance knowledge of Good Clinical Practice (GCP) and regulatory guidelines are essential in ensuring quality and compliance.

Job Duties and Responsibilities

• Manages and executes all aspects of study execution, including vendor selection and management, study start-up, enrollment management, and study close-out and reporting on assigned clinical trial(s).
• Provides operational leadership within the Operational Study Team and with cross-functional team members, study sites, and vendors.

• Develops and oversees the proliferation of study documents and plans to ensure adequate controls, aligning with GCP and regulatory requirements for study conduct. They will provide strong input into study protocols, informed consents, clinical study reports, and other clinical documents as appropriate for assigned studies.
• Oversees the set-up, maintenance, and completeness of the Trial Master File (TMF) for inspection readiness. They will review trial data to ensure completeness and accuracy of data and reporting in collaboration with other relevant functions.
• Collaborates with cross-functional teams and vendors on quality and compliance activities, ensuring continuous improvement in study conduct, proactively identifying and mitigating risks/issues to the study to ensure successful study conduct and reporting of study data.
• Management of the clinical study budgets and timelines of the study in collaboration with relevant functions.
• Responsible for selection, onboarding, training, and set-up of study personnel, CROs and other vendors, while regularly reviewing their performance to ensure compliance with contracts and expectations.
• Provides strong leadership to clinical operation team members on assigned studies, ensuring clear roles and responsibilities, and fostering a culture of collaboration and excellence. They may have direct line manager responsibilities.
• Contributes to department initiatives, workstreams and processes, including inspection readiness, as necessary.
• Contributes to the development and enhancement of organizational policies and procedures.

Key Core Competencies

• Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.
• Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English.  Ability to write reports, business correspondence and procedure manuals in English.
• Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
• Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Must be tactful, mature, flexible, and have well-developed interpersonal skills.  Ability to get along well with different personalities and to work well in teams.
• Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.
• Must have experience interfacing and managing multiple vendors/ contractors.
• Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.
• Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel.

Education and Experience

• Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.
• Minimum 8 – 12 (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in biotech or pharmaceutical industry or CRO setting, with specific expertise in Phases 1-4.

The base salary range for this role is $136,500 to $170,600.  Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.