Specialist Sr, Lead Clinical Research Associate
Responsible for driving the strategy and managing the execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.
- Key Responsibilities
Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials.
Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
Ensures the project team maintains a continuous state of audit readiness.
In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
Informs and presents study progress and known risks to Clinical leadership.
Recruits, manages and develops Principals, Associates and Specialists. Mentors and coaches all level of Project Management.
- Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- Job Scope and Leveling Guidelines
A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.
Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
Planning and Organization
Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
Discretion/Latitude; Supervision Received; Decision Making
Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
Business Relationships and Project Management
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
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