Associate Director, Clinical Operations Resume Sample
Emmet Kassulke
48995 Casimer Forks,
Phoenix,
AZ
+1 (555) 447 2742
Work Experience
Associate Director, Clinical Operations
01/2016
-
PRESENT
Philadelphia, PA
- Selects sites and countries; develops relationships with investigators and site staff
- Contribute to individual and team development through training initiatives and team building activities
- Contribute to strategy and direction to establish objectives for the overall operation for a clinical trials organization. Lead implementation of strategy for organization
- Implement and maintain quality control standards, and evaluate program effectiveness
- Negotiate with internal departments and external agencies (FDA, NIH, Hospitals) with authority to commit resources and effort
- Collaborate with Hospital and SoM leadership on the direction of clinical research and operational objectives. Develop strategies to ensure effective achievement of objectives (both short and long term)
- Serve as a liaison to external organizations/agencies. Negotiate and establish external resource contracts
- Participate in the evaluation and submission of grant applications in support of clinical research infrastructure and operations for multiple trials
Associate Director Clinical Operations
11/2012
-
11/2015
New York, NY
- Monitor affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research
- Manage operational budget, assign resources within budget constraints, secure resources for new initiatives, report on financial health of operations
- Responsible for oversight of multiple clinical trials and or smaller program(s) within Clinical Operations
- Responsible for managing multiple clinical trials within a program depending on the business needs of the department and the company
- Along with operational oversight, the individual is accountable for supporting achievement of assigned company and departmental goals
- Accountable for management of staff at the Sr. CTM level and below
- Provides leadership, guidance and direction to assigned staff, as well as, ensuring growth and development of direct reports
Education
Warren National University
2007 - 2012
Bachelor's Degree in Health Administration
Professional Skills
- Demonstrated excellent oral, written and presentation communication skills at all levels in the company
- Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
- Strong customer service orientation and experience in recovery and resiliency practices and programs. Strong data analysis and PC proficiency
- Outstanding computer skills including MS Office
- Professional experience including experience iin healthcare, life sciences, or consulting in those industries
- Expertise in outsourcing and CRO management; outstanding budget oversight and adjudication skills
- Highly analytical, scientific mind with exceptional problem-solving skills
How to write Associate Director, Clinical Operations Resume
Associate Director, Clinical Operations role is responsible for trials, finance, training, integration, database, auditing, compensation, reporting, design, research.
To write great resume for associate director, clinical operations job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Director, Clinical Operations Resume
The section contact information is important in your associate director, clinical operations resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate Director, Clinical Operations Resume
The section work experience is an essential part of your associate director, clinical operations resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate director, clinical operations responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate director, clinical operations position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Director, Clinical Operations resume experience can include:
- Strong ability to build peer relationships and communicate effectively with company disciplines, cross-functional, and external teams
- Work with Country/Region Leadership in formulating effective strategic goals and objectives and assure operational alignment with senior management priorities
- Demonstrated experience managing and mentoring clinical team members
- Demonstrate experience of study start up and vendor oversight
- Demonstrated ability to be highly effective and influential in a dynamic, rapid growth environment
- Negotiate effectively with colleagues to accomplish shared goals
Education on an Associate Director, Clinical Operations Resume
Make sure to make education a priority on your associate director, clinical operations resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate director, clinical operations experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate Director, Clinical Operations Resume
When listing skills on your associate director, clinical operations resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate director, clinical operations skills:
- Excellent Clinical Project management leadership skills
- Proven experience leading delivery through internal and external organizations
- Proven experience in the pharmaceutical or biotechnology industry
- Experience and strength in working and leading in matrix teams
- Proficient in written and oral communication and experience in presenting to groups
- Prioritize and manage multiple tasks; strength in organization and planning
List of Typical Experience For an Associate Director, Clinical Operations Resume
1
Experience For Associate Director Clinical Operations Resume
- Develops and maintains effective working relationships with internal stakeholders and external partners
- Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
- Relevant work experience with at least 5 years at biotech, pharmaceutical or CRO within clinical development or related functions
- Previous experience with a team of direct and indirect reports
- Building, managing, and maintaining high performing clinical teams
- Develop and ensure adherance to integrated site monitoring, data handling and review plans
- Responsible for initiating the development of operational strategy within the program or TA in collaboration with key cross functional stakeholders
- Initiates and implements resourcing strategies to mitigate attrition and provide a best case strategy for the department and the company
- Implements performance standards and is responsible for developing performance metric reports across assigned programs or therapy area
2
Experience For Associate Director, Clinical Operations Dcri Resume
- Knowledge of regulatory start up process and planning in support of study start up
- Contribute to statistical analysis plans, ensuring clinical trial objectives are aligned with the delivery of evaluable data
- Participate in due-diligence activities for in-licensing of new products
- Participates in departmental business initiatives to support best practice across Clinical Operations
- Lead and participate in the development of process improvement standards, policies and SOPs
- Interacts with senior and middle management to report Clinical Operations metrics to include study and or program milestones
3
Experience For Associate Director, Clinical Operations Resume
- Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team
- Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
- Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence
- Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance
- Guide junior CTM’s on Good Clinical Practices (GCP), monitoring activities, and compliance
- Demonstrated ability to influence and lead others to deliver quality results in a timely manner in both independent and team environments
- Demonstrated competency with project management processes and procedures
- Be responsible for and manage clinical research activity of Clinical Trial Managers, Clinical Trial Specialists and contract CRAs
4
Experience For Associate Director Clinical Operations Resume
- Prepare clinical research budgets and timelines
- Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
- Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Support the implementation of new clinical systems/processes, and provide support for publications, as needed
- Daily interaction with study Medical Director and members of the cross-functional study team; leads the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)
- Contributes to individual and team development through training initiatives and team building activities
- Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including BioMarin SOPs, ICH and FDA and other Health Authorities (HAs))
5
Experience For Associate Director, Clinical Operations Dcri Resume
- Oversee study feasibility assessment activities (if applicable)
- Ensure timely development and finalization of key study plans and manuals as per the Study Team charter
- Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, and others
- Identify CLO risks and mitigations and align with cross-functional Study Team on overall Risk Mitigation Plan
- Identify, resolve or, if necessary, escalate CLO issues that have a significant impact to overall study timelines, other functions, budget or quality to Study Team Lead as per Study Team charter
- Provide CLO study activity timeline and budget inputs to overall Study Team timeline and budget
6
Experience For Associate Director, Clinical Operations Resume
- Lead cross-functional effort to define enrollment strategy and plan for the study
- Provide study status updates to the Study Team and Study Team Lead
- Actively participates as the organization’s representative on boards, community and health-related agencies
- Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally, and to communicate complex issues in a sound and understandable way
- Experience with clinical operation infrastructure including writing, developing and implementing development tools and SOPs
- Proficiency in MS Office package MS Access, MS Excel and MS Project
- Direct the development and execution of business and operations strategy for our next generation health clinic in close collaboration with the Medical Director
- Envision and launch technology-enabled healthcare products and services in partnership with our clinical and research teams
- Develop a scalable, sustainable business model for our next generation health clinic
7
Experience For Associate Director Clinical Operations Resume
- Recruit and develop a clinical operations team
- Ensure and maintain compliance with mandated regulatory programs
- Institute quality assessment and improvement processes
- Monitors, controls and reports performance of vendors against timeline, deliverables, budget and quality expectations
- Signs documents for activities as authorized and described by Endo policies, procedures and job descriptions
- Ensure operational excellence and integrity through adherence with Endo policies and procedures, GCP, ICH, FDA and all other international regulatory requirements
- Manage cross-functional team to the achievement of clinical trial goals
8
Experience For Associate Director, Clinical Operations Dcri Resume
- Establish and ensure adherance to study timelines in collaboration with study team; report progress and timeline deviations and manage stakeholders
- Proactively identify project risks and develop plans to mitigate them
- Assist with protocol design, consult on operational/logistic issues and ensure all operational aspects of the clinical trial are satisfactorily addressed
- Facilitate and assist in the preparation of patient study related materials and documentation
- Drive data quality management processes to identify critical data elements and ensure their efficient collection for central monitoring and statistical analysis
- Drive site selection and patient recruitment programs that deliver enrollment targets
- Establish a visible Endo profile with investigator sites during study start up and ensure site-to-sponsor communication is effective and efficient throughout the trial
- Ensure electronic clinical data streams are defined, understood by the study team, optimally sourced and efficiently implemented
9
Experience For Associate Director, Clinical Operations Resume
- Ensure analysis-ready, clean databases are delivered that accurately reflect study conduct and support regulatory submissions/scientific publications
- Train and supervise staff assigned to clinical trial projects
- Pro-actively manage and monitor Trial Master Files (TMF); ensure TMF components in custody of vendors are available and inspection ready
- Assist with the preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
- Contribute to the development of clinical study reports
- Monitor and report on key performance indicators
- Manage and coordinate with external service providers including clinical research organizations (CROs), EDC platform providers, laboratories and others, serving as primary point of contact, preparing scopes of work, ensuring agreed deliverables are achieved on time and monitoring key performance indicators
- Provide formal oversight and ensure inspection-ready documentation exists for sponsor obligations transferred to CROs and other providers
- Contribute to cross-functional projects
10
Experience For Associate Director Clinical Operations Resume
- Mentor and develop clinical trial team members
- Lead process improvement projects and other initiatives within clinical operations and data management
- Interacts closely with Prestige, the state of Florida providers and other stakeholders in the success of the BH program
- Oversees the clinical and administrative supervision of Medical / Behavioral Integration staff
- Formulates action plans to remedy any findings from the provider audits, utilization reports, provider concerns or in response to Prestige concerns
List of Typical Skills For an Associate Director, Clinical Operations Resume
1
Skills For Associate Director Clinical Operations Resume
- Solid experience with project management, resource management, administrative and technical skills
- Strong risk management, communication, interpersonal and organizational skills
- Superior interpersonal skills coupled with multicultural awareness
- Clinical Operations experience in biotech or pharmaceutical industry and/or CRO experience
- Direct CRO oversight experience or extensive CRO experience
- Solid leadership and management experience in the industry
- Able to work on multiple projects and effectively manage time and resources
2
Skills For Associate Director, Clinical Operations Dcri Resume
- Increasing responsibility in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design
- Strong understanding of R&D and the drug development process
- Non Interventional Organised Data Collection initiatives, including Non Interventional-and Real World Evidence studies
- Valid NV Driver’s license
- Experience in both early and late phase development
- Clearly demonstrates the capability and potential to advance within the organization
3
Skills For Associate Director, Clinical Operations Resume
- Demonstrated ability to set and communicate standards from both a strategic and tactical perspective
- Ten + years of experience in the pharmaceutical/biotech industry
- Foster strong relationships and networks within Mount Sinai Health System
- Understanding performance metrics data and how to implement and utilize these data to drive operational performance
- Participates in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meeting
4
Skills For Associate Director Clinical Operations Resume
- Deep understanding of the complex healthcare landscape and associated stakeholders including clinical, regulatory, financial, and policy components
- Participate in strategic study planning meetings (such as DMC, advisory board, steering committee)
- Accountable for driving accurate clinical resource forecasting
- Master’s in Business, Management, Nursing, Public Health or related field
- Advanced understanding of Clinical Operations and ability to assist in protocol design
- Successful track record of delivering clinical trials on schedule and within budget and quality parameters
- Expertise in risk mitigation, problem-solving, and program-level resource and budget management
- Comprehensive understanding of Pharmaceutical requirements and impact on clinical trail operations
- Ensure completion of clinical activites to achieve database lock according to agreed timeline
5
Skills For Associate Director, Clinical Operations Dcri Resume
- Assist in preparation of Investigator Alert letters and SAE reports as required to ensure reporting timelines are met
- Partner with outsourcing on vendor selection, operational, assessments, contract management and invoice approval
- Coordinates day - to - day BH operations to achieve goals and ensures smooth and efficient functioning to meet the requirements of the Prestige contracts
- Provides mentoring to junior team members and/or management and development of direct reports, as required
- Reviews and approves specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials
- Plan and lead interactions, including issue escalation and resolution between Clinical Operations, Clinical Trial Teams (CTTs), CST and the PDT/GPT
- Motivate team members and build cross functional teams in support of the PDT/GPT vision
- Expertise with clinical and research regulations and processes
6
Skills For Associate Director, Clinical Operations Resume
- Work with diverse disciplines: medical doctors, research scientists, software engineers, industrial designers, hospital and business administration, entrepreneurs
- Anticipate problems and innovate effective plans for complex situations
- Broad and deep understanding of clinical trial management for the operational planning, execution and delivery of clinical studies domestically and globally
- Process-driven, detail-oriented, and action-biased approach
- Your past might also include
- Well versed in GCP and applicable FDA/EMEA/ROW regulations
- Competency in the principles of clinical data management, data standards (e.g. CDISC) and the various tools and processes used to collect and manage clinical data from source (site) through lock
7
Skills For Associate Director Clinical Operations Resume
- Demonstrated ability to lead multi-disciplinary teams to the achievement of project goals
- Knowledgeable in the interaction between clinical operations and data management with a focus on the integration of the two disciplines
- Work with clinical trial and clinical data management systems, MS Office, electronic document management and other web-based systems
- Works autonomously under consultative direction toward long range goals
- Communicate proactively and appropriately and various levels within the organization and externally
- Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers
8
Skills For Associate Director, Clinical Operations Dcri Resume
- Strong report writing capability required
- Consult and collaborate confidently with senior scientific and clinical research professionals
- Standard office environment and daily commute to assigned office location
- Independently licensed as either a Doctor of Psychology, Masters - level Social Worker or Professional Counselor in the state of FL required
- Strong preference given to candidates with administrative experience in the Florida SMMC/MMA mental health and substance abuse service delivery system and in administering a similar contract
- Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA)
9
Skills For Associate Director, Clinical Operations Resume
- Experience in clinical trial conduct in multiple phases of development across several therapeutic areas is required
- Experience in CRO, vendor and laboratory selection and oversight is required
- Oncology clinical trials experience (5 years)
- Successful experience in a large pharmaceutical company and complex matrix-based organization
- Expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes
- Confident operations leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff in a matrix environment to achieve corporate objectives
- Able to successfully establish relationships, communicate effectively within/across company disciplines and thrive within a global, highly matrixed organization
- Skilled at leading external teams at remote locations
10
Skills For Associate Director Clinical Operations Resume
- Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials with short timelines in a fast-paced setting
- Clinical monitoring and auditing experience
- Experience in multiple therapeutic areas including oncology
- Experience managing clinical operations teams
- Line management experience
- Attention to detail and commitment to high quality and on-time deliverables
- Easily gains trust and support of peers; encourages collaborations
- Interpret the impact of the regulatory environment and anticipate changes to deliver operational goals
List of Typical Responsibilities For an Associate Director, Clinical Operations Resume
1
Responsibilities For Associate Director Clinical Operations Resume
- Represents Optum in relevant organizations and meetings
- Provides leadership and direction in the development of appropriate risk management strategies
- Works closely with Prestige, providers and stakeholders to implement these strategies
- Evaluate regional workload, quality and budget metrics through regular review and report of findings
- Evaluate clinical performance for key projects/ programs in the region through regular review and report of findings
- Collaborate with Senior Management, countries and other functional leadership to improve efficiencies, outcomes and quality outputs for clinical activities
- Works collaboratively with internal functional leadership to manage challenges and to achieve exemplary customer service through delivery of the clinical projects
- Develop standard processes to ensure consistent delivery of clinical projects in the region
- Provide strategic leadership for clinical resourcing processes & outcomes, onboarding and training standards within the region to ensure project resources are appropriately allocated
2
Responsibilities For Associate Director, Clinical Operations Dcri Resume
- Support financial activities that reconcile finance forecast and budget with resourcing needs and recommend opportunities to optimize through regular review and analysis of clinical resourcing
- Provides management of a clinical study(s) and clinical operations aspects of a drug development program
- Manages and supervises the operational aspects of Insmed’s clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites
- Leads CRO and other vendor selection and reviews contracts/work orders
- Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress
- Participates in SOP and process development activities for Clinical Operations functions
- Manages clinical program budgets and execution program timelines
- Oversees in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
3
Responsibilities For Associate Director, Clinical Operations Resume
- Participates in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials
- Presents trial status and clinical operations strategy to project team and management
- Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs
- Attends site visits to ensure oversight of CRO
- Provide expert clinical operational input into: Target Product Profile (TPP) Clinical Development Plan (CDP), Protocol Concept Sheet (PCS), Clinical Study Protocol (CSP), and Clinical Study Report (CSR), to ensure seamless delivery of studies through effective collaboration
- With oversight from the Director or Sr Director, deliver differentiated and robust operational design options for review at Investment Decision Governance interactions (ie. PDT, iMED, Clinical Functional Review, ESPC and others as appropriate)
4
Responsibilities For Associate Director Clinical Operations Resume
- Oversee the operational delivery of the Clinical Study Program(s) from CD Nomination to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs)
- Review of the CSRs and any regulatory submissions. Co-leads the clinical operational team contribution along with Regulatory
- Accountable for the quality of study delivery planning information into relevant planning systems (eg: OPAL, IMPACT) and the direct input of clinical forecasting into OPAL
- Line management of 0 to 4 direct reports- CPMs/Sr CPMs/CPCs
- Serves as operational subject matter expert and primary point of contact for research projects driven by Medical Affairs at a global or regional / affiliate level
- Act as liaison between Clinical Operations and other cross – functional stakeholders in the conduct of Medical Affairs research activities. (Medical Affairs, Biometrics Data Centre , Pharmacovigilance, Regulatory, Quality Assurance, Commercial)
5
Responsibilities For Associate Director, Clinical Operations Dcri Resume
- Establishes and maintains the global operational and procedural framework for the compliant conduct of Medical Affairs research activities
- Supervises the Therapeutic Area Review Committee process for Medical Affairs research activities
- Provides oversight for all types of Medical Affairs research projects at the global or regional / affiliate level
- Provides operational leadership for global Medical Affairs research projects including planning and execution in close collaboration with Global Medical Affairs and the Data Science team
- Provides hands-on operational support to affiliates/regions in the conduct of Medical Affairs research activities including planning and execution
- Develops, implements and maintains standards across clinical studies within a program including but not limited to new hire training for CTMs/CRCs, tools, templates and CRO manuals
- Hire, supervise and train operations personnel (CTM and/or CRC) and takes ownership of the quality of assigned clinical programs and deliverables. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations
6
Responsibilities For Associate Director, Clinical Operations Resume
- Investigator Initiated Studies
- Business travel ~30%
- Courage & Candor
- Manage staff in accordance with organization’s policies and applicable regulations if needed. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
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