Associate Director Clinical Operations

Overview

We are currently searching for a skilled professional to join a well-known client’s team in North Carolina as an Associate Director of Clinical Operations. This remote role will oversee the operational leadership and execution of clinical trials and programs in the therapy area of CNS disorders. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

• Manage study timelines, budgets, CROs, vendors, and consultants for the conduct of clinical studies
• Maintain expert knowledge of the CNS therapeutic area and CNS indications
• Lead cross-functional teams and shape team dynamics to support collaboration and accountability
• Oversee performance of one or more clinical studies and serve as the point of contact for all CROs and vendors
• Develop and ensure execution of activities outlined in various study plans
• Set up study systems with CROs
• Identify and communicate study-related issues and facilitate discussion of potential solutions that can be implemented by the team
• Manage study resources, internally and externally, to optimize performance to study deliverables
• Escalate changes in scope appropriately
• Create/manage standardized clinical trial tools, processes, and SOPs

Experience

• Minimum of 8 years of pharmaceutical or biotechnology industry experience required
• Minimum of 5 years direct study management work preferred
• Sponsor (pharma or biotech) experience preferred
• Experience in CNS/neurology required
• Experience in Phase 2 and Phase 3 multicenter studies of mood disorders (MDD) in US/global settings preferred
• Experience with rater training management and developing relationships with sites/Key Opinion Leaders (KOLs) preferred
• Detailed knowledge of GCP/ICH guidelines, clinical trial monitoring, and regulatory compliance
• Experience managing CROs, vendors, budgets, and timelines
• Experience working with all levels of management and an ability to influence the optimization of outcomes
• Strong interpersonal, communication (written and verbal), and organizational skills
• Excellent problem-solving, interpersonal, and leadership skills

EDUCATION

• Minimum of Bachelor’s Degree required
• Advanced Degree preferred

To Be a Best-fit Your Strengths Must Include

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent and Client, visit [ Link removed ] - Click here to apply to Associate Director Clinical Operations

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available. 504363