Sr Mgr Clinical Trials

Overview

The Sr Manager, Clinical Trials will be responsible for the effective management and operations of assigned investigative studies in line Myriad's Clinical Development goals, particularly in collaboration medical leadership, principal investigators, and study operational leadership, and for integrating clinical development objectives with system/inter-departmental considerations and strategic business decisions. The Sr Manager, Clinical Trials leads the tactical implementation and conduct of clinical research studies and is a direct supervisor of one or more Clinical Research Associates/Assistants, can function with minimal oversight and direction, provides study operational guidance to peers, and supports the Director, Clinical Operations in leadership of all aspects of study execution.

Location: San Francisco Bay Area (preference)

Hybrid/Remote

CLIA Title:New York State Title:

Responsibility

1. Supports and/or leads the development of the study operational plan and associated study content including risk assessments, monitoring plans and communication plans and contributes scientific/clinical information aligned with the strategy.
2. Manages study start-up and monitoring activities and leads collaborations with study sites.
3. Develops and manages resourcing plans for studies.
4. Develops and recommends project budgets and may authorize study-related expenditures.
5. Assists in the development of clinical trial agreements.
6. Tracks study progress and implements appropriate actions to maintain enrollment goals.
7. Assesses reported protocol deviations and takes appropriate corrective actions.
8. Ensures resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with study sites.
9. Provides operational review of study-specific documentation and training materials.
10. Ensures adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols].
11. Monitors compliance with agency and institutional regulations on clinical studies.
12. Facilitates team meetings with various Business Units on key projects and provides project updates to key stake holders within the organization.

Qualifications

1. Bachelor's Degree: RN/BS/BA; scientific discipline preferred.
2. Minimum of 3 years of Clinical Trial Management experience or comparable management responsibility.
3. In-depth knowledge of clinical study operations.
4. Experience in study design/trial management and reporting.
5. Knowledge of medical terminology, clinical monitoring procedures (SOPs), and ICH/GCP guidelines.
6. Demonstrated success in leading a cross-disciplinary, research-focused team.
7. Excellent attention to detail and organizational skills.
8. Ability to lead teams in producing quality work in fast-paced, deadline-driven environment.
9. Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
10. Excellent collaboration skills and commitment to individual and team professional development.

Physical Requirements

Lifting Requirements - light work or exerting up to 20 pounds of force frequently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions.

EEO

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.