Associate Director, Clinical Operations Job Description

Associate Director, Clinical Operations Job Description

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Associate director, clinical operations provides financial and operational support to Clinical Operations Team across multi-phase Clinical Studies with emphasis on CRO and specialty vendors management and financial operations.

Associate Director, Clinical Operations Duties & Responsibilities

To write an effective associate director, clinical operations job description, begin by listing detailed duties, responsibilities and expectations. We have included associate director, clinical operations job description templates that you can modify and use.

Sample responsibilities for this position include:

Support GCP SOP development and serve as quality operations reviewer
Lead inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and manage back room during GCP inspections
Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues
Administering, directing, planning and coordinating business and clinical activities for multiple medical offices/departments
Working collaboratively with the physicians to ensure high quality, cost effective and accessible patient care services
Administering the patient/nursing services for selected medical offices / departments
Provide internal communication of important clinical data and events
Partnering with development team(s) to drive quality within the team(s)
Develop and implement quality management plan for each assigned program
Interpret and provide key metrics to Global Development Team Leader and cross-functional development team members

Associate Director, Clinical Operations Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Associate Director, Clinical Operations

List any licenses or certifications required by the position: CPSM, PMP, D.O, M.D, PALS, APICS

Education for Associate Director, Clinical Operations

Typically a job would require a certain level of education.

Employers hiring for the associate director, clinical operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Life Sciences, Nursing, Education, Health Care, Science, Life Science, Medical, Management, Leadership, Health

Skills for Associate Director, Clinical Operations

Desired skills for associate director, clinical operations include:

Clinical development processes with strong emphasis on monitoring
Relevant Therapeutic Areas is an asset
Clinical research financial parameters and project financial tracking and accounting methods
Budgeting
GCP
Regulatory compliance
Applicable business tools and systems
Financial concepts as related to forecasting
Proposal generation
CRA

Desired experience for associate director, clinical operations includes:

Execute risk-based methodologies for the planning and execution of clinical protocols , assuring an ongoing cycle for Plan – Do – Check – Act
Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development
Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation
Assure appropriate escalations and notification to line management
Manage temperature excursions occurring during shipment and site/patient home storage
Mentor other Clinical Quality Operations Quality Leads

Associate Director, Clinical Operations Examples

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Associate Director, Clinical Operations Job Description

Job Description Example
Our company is searching for experienced candidates for the position of associate director, clinical operations. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for associate director, clinical operations
  • Responsible for identifying and developing technologies and business practices to support Lean manufacture and gain competitive advantage
  • Provide technical input on batch processing
  • Development of staff and creation of an ownership culture through targeted leadership assignments, training and technical development opportunities
  • Develop and define interfaces with partner groups and establish clear channels for external collaboration for the IPT's process group
  • Establish objectives for the IPT's process group
  • Assign IPT staff as appropriate to meet campaign requirements
  • Develop each staff member in a way which focuses on gaining fluency in the targeted behaviors and competencies required of each team member
  • Participate in Management Staff meetings
  • To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within the Medicine Business Unit
  • To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts
Qualifications for associate director, clinical operations
  • Minimum 5 years of experience with a heavy focus on sterile product formulation and filling technology
  • Minimum 3 years of team management responsibility
  • Strong understanding of process equipment and best practices related to equipment use
  • Champion of new ideas and MPS, embraces change
  • Sound decision making skills, drives results
  • Able to work collaboratively with a diverse workforce, both inside and outside IPTs
2

Associate Director, Clinical Operations Job Description

Job Description Example
Our innovative and growing company is looking for an associate director, clinical operations. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for associate director, clinical operations
  • To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing
  • In particular, this position will provide compliance business partner support for the Clinical Operations, Quality Medicine, Biometrics & Data Services, Medical Sourcing, Epidemiology, Pharmacovigilance, Clinical Development Medical Affairs Immunology, Biosimilars and CNS departments within the Medicine Business Unit
  • Serve as a “single point of accountability” for assigned Medicine business partners and provide compliance expertise and guidance, including the business acumen necessary to develop alternative solutions to achieve business objectives and enable decision-making that stays within ethical boundaries while still optimizing business performance
  • Assesses training needs for assigned Medicine business partners, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area
  • Collaborate with internal Ethics and Compliance Department team members to identify areas of compliance risk in respective business areas, including but not limited to topics related to the principles of scientific exchange and promotion, health care provider engagements, Transparency & Disclosure, CIA, Anti-Bribery and Anti-Corruption (ABAC), and ensure that systems, policies, procedures, training and other resources are coordinated to mitigate risk to impacted business areas
  • Demonstrate expert working knowledge of GHI study initiation, execution, analysis and closing procedures
  • Lead study and clinical team meetings
  • Mentor junior CTMs and CTAs
  • The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
  • Uses operational and therapeutic expertise to optimize trial design and execution
Qualifications for associate director, clinical operations
  • Minimum of five (5) years Pharma and/or related experience
  • Bachelor’s degree and/or Master’s in Law or related field
  • Strong performance history, including five (5) to eight (8) years or similar business experience in a pharmaceutical, biotech or life sciences setting and two (2) to five (5) years of prior experience in compliance, regulatory and/or other compliance- related role
  • Strong interpersonal and management skills and experience
  • Demonstrated ability to critically analyze and assess business and regulatory information and effectively communicate up, down and across the organization
  • Leadership experience and results orientation
3

Associate Director, Clinical Operations Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of associate director, clinical operations. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for associate director, clinical operations
  • Act as a coach and mentor for staff members as they develop in their roles
  • Managing the operations aspects of the OpsI Suspects generation program which involves interacting with development partner and internal clients
  • Serving as the POC and decision maker on operational activities
  • Provides status updates across and to Sr
  • Takes true ownership of the Business Suspects generation process and provides constructive information to minimize problems and increase provider and market satisfaction
  • Partners with Care Delivery leadership teams and Optum Insight to coordinate execution and implementation of prioritized work
  • Through critical thinking and analysis, works to identify issues within the process and work towards resolving them through root cause analysis
  • Work with partners to drive improvement and change for the betterment of the program with focus on providing actionable information to the client and driving satisfaction
  • True champion of the program to stakeholders and drive work through strong personality and leadership
  • Be comfortable in providing direction and guidance from Business side to ensure proper comprehension of the work and delivery
Qualifications for associate director, clinical operations
  • Experience executing both Phase II & III drug and Class II & III medical device clinical trials is required
  • Functions effectively in a dynamic environment while balancing needs of process development and clinical production
  • Focused on leadership development of staff
  • Candidates must be “current” on emerging technologies used to streamline and run “flawlessly” Global Development Operations processes, especially focused on leveraging technology to Clinical Operations and CRO partnerships
  • Keenly developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments
  • Promote opportunities for applying technology to business problems
4

Associate Director, Clinical Operations Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of associate director, clinical operations. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for associate director, clinical operations
  • Managing a team of business analysts to support the execution of the enterprise clinical capability programs
  • Serving as the point of contact and decision maker on operational activities
  • Provides status updates across and to senior leadership
  • Takes ownership of the Business Suspects generation process and provides constructive information to minimize problems and increase provider and market satisfaction
  • Partners with clients and internal partners to coordinate execution and implementation of prioritized work
  • Ability to work independently and in a team environment to deliver on Clinical Suspect Program
  • Ability to influence and work with internal and external stakeholders / resources to move the program forward and overcome any challenges
  • Oversee the strategic selection of program-wide vendors
  • Develop and assess cost and resource projections of program for portfolio plan and business development opportunities and serve as point of contact
  • Represent the clinical operations program on strategic governance bodies (e.g., Product Safety Team, Global Project Team)
Qualifications for associate director, clinical operations
  • Reviews critical study documents created by CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools
  • Regular travel, approximately 30% of work week
  • 10+ years of health plan or clinical care management with progressive operational experience
  • RN Clinical background
  • 10+ years of experience in managing multi stakeholder enterprise level programs through all the phases using PM best practices
  • Advanced proficiency in Microsoft Office applications, MS Project and Visio
5

Associate Director, Clinical Operations Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of associate director, clinical operations. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate director, clinical operations
  • Ensure effective project or program communications to internal and external stakeholders through meetings, presentations, and other methods
  • Accountable for successful implementation of biomarker operations for compounds in Phase 1-3 clinical trials, including timelines and quality metrics
  • Oversee implementation of biomarker operations strategic plans
  • Demonstrated ability to manage international biomarker programs within designated program budgets and timelines is required
  • Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents which have biomarker operations components
  • Represents the company at professional events and present company clinical initiatives and findings at such events
  • Initiate continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Oversees the day to day operations and quality assurance of clinical research programs at Duke affiliated sites
  • Reviews and supervises activities performed by research staff involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements
  • Establishes and implements guidelines for the collection of clinical data and/or administration of clinical trials as specified by protocol
Qualifications for associate director, clinical operations
  • Previous experience working with and analyzing large healthcare data sets
  • Lead manager of protocols
  • Relevant direct pharmaceutical industry experience in Clinical Trial Supply or Ancillary Supply
  • Building and retaining good client relationships in the biopharmaceutical industry
  • Involvement in change projects
  • Proven ability to solve complex business problems and make tough decisions

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