Clinical Development Resume Sample
Cathrine Johnston
57938 Nick Trace,
Phoenix,
AZ
+1 (555) 507 5929
Work Experience
Clinical Development Manager
09/2016
-
PRESENT
Philadelphia, PA
- Motivated to positively impact the healthcare industry and ultimately patient’s lives
- Participates in customer proposals, Request for Information (RFIs), presentations, proposal defenses and Steering Committees
- Apply in-depth knowledge of the operating room environment and of the da Vinci®Surgical System in order to become an expert within the company on the clinical application of Intuitive’s products
- Keep the organization’s vision and values at the forefront of decision making and action
- Work in close collaboration with Research, Clinical Development (CD) functions, Regulatory Affairs, Non-Clinical Development, Product Development, Commercial/ Business Development and Project Management
- Develop early clinical development plans for assigned projects
- Establish strong relationships with senior external experts
- Provide leadership for first-in-human (FIH) study conduct and , when required, lead Early Clinical Development’s FIH Committee
- Have a proven ability to provide medical knowledge in a range of areas, including (though not solely) immunology, respiratory and hematology; and
Clinical Development Liaison
03/2012
-
07/2016
Chicago, IL
- Demonstrates a thorough command of all EP capital and disposable products, including the EnSite System related product and technical knowledge, cardiac mapping and ablation techniques, trends, and competitive technologies. 3. Provides insight, guidance, and feedback to management on market feedback and components of next generation of products
- Supports the TAH developing new methodologies and leads development of and updates to disease area data standards for disease areas and indications within the TA
- Monitors rigorous adherence to quality and compliance
- Tracks updates of key clinical documents, in particular IDPs
- Responsible for resource planning for clinical functions (all levels of GPCH, CDD, and CDMD) in alignment with the TAH, GHCS and the Global Head Strategy & Operations. Supports recruitment of medical and scientific talent, making sure job criteria are applied consistently within TA/Development Unit (DU) and beyond
- Apply in-depth knowledge of the operating room environment and of the da Vinci® Surgical System in order to become an expert within the company on the clinical application of Intuitive’s products
- Drive the update of clinical documents template such as Clinical Trial Protocol, Informed Consent, Investigator Brochure and Integrated Development Plan according to clinical guidance
Clinical Development Intern
11/2009
-
12/2011
Chicago, IL
- Follows directions to complete assigned tasks under close supervision
- Reports problems and solicits direction from Supervisor
- Acts as the area’s senior most clinical EP resource, responsible for developing talent in EP clinical competence and leadership across both clinical and sales teams
- Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials
- Assists Sales with advanced product demonstrations to visiting physicians and sales personnel
- Assists Research and Development with projects focused on new product development, testing, validation, and collecting physician feedback
- Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends
Education
Grand View University
2003 - 2008
Bachelor's Degree in Life Sciences
Professional Skills
- Provide strategic leadership, proven decision-making skills, strong negotiating and conflict resolution skills is required
- Excellent English language communication skills. Demonstrated experience interacting with stakeholders in various challenging situations
- Provide strategic leadership, proven decision-making skills, strong negotiating and conflict resolution is required
- Strong interpersonal skills for interacting with managers at all levels and ability to perform effectively both in independent and team-based work environment
- Excellent communication skills and ability to effectively work with others
- Experience in providing work direction for others and have mentoring and interpersonal skills to train & manage a clinical support staff in China
- Demonstrate problem-solving and critical thinking skills
How to write Clinical Development Resume
Clinical Development role is responsible for leadership, presentation, design, training, conflict, negotiating, integration, database, oncology, planning.
To write great resume for clinical development job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Development Resume
The section contact information is important in your clinical development 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 Clinical Development Resume
The section work experience is an essential part of your clinical development 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 clinical development responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical development position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Development resume experience can include:
- Apply effective verbal, written and presentation skills along with proven organizational skills
- Excellent interpersonal skills, including the ability to deliver clear and effective messages both orally and in writing
- Good organisational and time planning skills
- Demonstrated leadership skills and involvement in shared governance work, quality improvement and performance improvement
- Excellent verbal, written, analytical, and presentation skills
- Highly effective verbal, presentation, and written communication skills
Education on a Clinical Development Resume
Make sure to make education a priority on your clinical development resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical development 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 Clinical Development Resume
When listing skills on your clinical development 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 clinical development skills:
- Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to insure timely project success
- Strong operational voice and influencing skills required
- Excellent interpersonal, influencing and communication skills (verbal and written) are required
- Proven competency of networking skills with external key opinion leaders and experts in specific therapeutic areas or scientific disciplines
- Excellent people leadership & development skills
- Demonstrated hands-on scientific and clinical development experience, 3 years experience
List of Typical Experience For a Clinical Development Resume
1
Experience For Clinical Development Manager Resume
- Influencing skills, ability to work in matrix environment
- Effective at handling multiple projects at one time and prioritizing to meet deadlines
- Engage staff in key initiatives by effectively communicating the “why” / teachable point of view (TPOV)
- Proven experience in managing external stakeholders/CRO programs is required
- Strong clinical project management experience in biotech, pharma or CRO environment is required
- Understand clinical applications in a variety of fields and communicate effectively with physicians
- Strong business acumen and experience in the life sciences industry
2
Experience For Clinical Development Specialist Resume
- Project coordination experience project support with specific experience with database management, tight timelines, and team coordination
- Collaborating with academic thought leaders and KOLs, and maintaining excellent working relationships with technical consultants
- Coordinating and setting agenda and priorities for Development team meetings
- Broad knowledge of the drug development life cycle and clinical trial methodology, including solid working knowledge of GCP and ICH
- Successful track-record of building and maintaining strong internal and external relationships
- 2~3 years specific experience with independent daily judgment, problem solving and decision making required minimal supervision
- Min. of 5 years’ experience in MR, including all clinical applications and performing procedures
- A fast-mover who adapts quickly to changing priorities, is willing to wear many hats
- Create and manage process for the evaluation and validation of marketing claims for da Vinci® Surgical System products
3
Experience For Clinical Development Liaison Resume
- Ensures effective management of the study plan including all activities, budget and timelines
- Experience in managing external stakeholders/CRO programs is required
- Experience leading a global R&D registration program is required
- Perform targeted sites prospecting in alignment with portfolio strategy & priority
- Display good judgment and problem solving abilities
- Experience in managing external stakeholders/partners/CROs required
- Experience in driving innovation within teams and programs required
- 4 years experience in nursing or allied health
4
Experience For Clinical Development Engineer Resume
- Experience with curriculum development and use of variety of learning methods
- 4 years experience in nursing
- Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
- Have demonstrated your understanding of the study, project, and program level and can function successfully across a variety of projects
- Demonstrate Innovation Characteristics
- Conduct pre-clinical validations and design iteration assessments of products both internally and with external key opinion leaders
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations
- Demonstrated ability to work collaboratively with internal and external partners
5
Experience For Senior Clinical Development Manager Resume
- Strong demonstration of initiative and follow through
- Working with the Clinical Development Manager, design and conduct clinical and claim substantiation studies, progressing to independently managing projects
- Directing and coordinating the activities of all project related functional teams when serving in the capacity of Project Lead
- Developing study designs and negotiating costs to ensure compliance with budgetary appropriations
- Bring real time issues to immediate supervisor
- Coordinating Scientific Group meetings
- Understanding of and insight into the interests and concerns of study centers
- Collaborate with other organizations within the company as needed, including regulatory, marketing, training, and sales
6
Experience For Clinical Development Consultant Resume
- Lead operational input to proposal development and pricing including proposed program strategy
- Implement best practices and standards for trial management, including sharing lessons learned
- Direct sales organizations on all market development related activities. Manages messaging and requests for training, clinical education, KOL, congress/event
- Act as the single point of accountability within GCDO at the global program level and be accountable for leading high performing teams
- Assist in coaching, developing, recognition when needed
- Ensures accurate maintenance and archiving of study records including eTMF
- Appropriate expertise in financial modeling and written presentations including Excel, Word and PowerPoint
- Coordinate and maintain the continuing education process for Advocate according the ANCC and ONA standards
7
Experience For Associate Director, Lean Clinical Development Resume
- Established reputation for working within a team and developing cohesiveness for all team members
- 4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts (CSE)
- Develop high standards of data analysis, critical thinking, and communication for the advancement of clinical programs and competencies
- Develop an understanding of Clinical and Quality Systems and key quality indicators used in healthcare organizations
- Assist in developing a clinical trial strategy and design, as well as support trial execution in conjunction with ISI & JV Clinical- and Clinical Affairs teams
- Facilitate information exchange between engineering team in California and clinical support staff in China
8
Experience For Director of Clinical Development Resume
- Timely submission and delivery of high quality clinical program data supporting regulatory approval of key compounds (or new indications), as appropriate
- Plays a leadership role in matrix teams managing the day-to-day conduct of the study(s) from a medical perspective
- Contributes to development of regulatory/safety documents relevant to ongoing clinical trials
- Contributes to decision-making both within the project team and with external stake-holders
- Partners with Clinical Operations study management staff to ensure appropriate conduct and reporting of clinical studies to agreed timelines
9
Experience For Executive Director / VP, Clinical Development Resume
- Ensures completion of medical governance and regulatory reporting at the start to ensure overall safety of the study subjects
- Ensures safety of study subjects through sound study design and analysis, and appropriate medical monitoring of the study
- Ensures all regulatory reporting requirements are met
- Work closely with Calibr translational sciences and clinical teams to manage ongoing activities and make recommendations to management and the advisory board
- Proactive risk management and mitigation planning from the start of a clinical development program (IDP) until closure
- Lead CRO selection, ensure scope of work is defined and define deliverables, turnaround times, and quality and performance levels for new sourcing needs
10
Experience For VP, Clinical Development, Neurology Resume
- The ability to collaborate with all levels and influence decision-making in a global, matrix environment is required
- Maintain Safe Fleet standards according to Company guidelines
- Participate in daily huddles as able and is a knowledge resource for nurses and clinical staff enabling them to care for patients
- Ensures a Lessons Learned meeting takes place, captures and shares cross functional study team practices
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
- Extensive computer knowledge, including ability to solve simple technical problems
- Flexibility, a desire for continuous learning, and a commitment to service excellence
- Strategic mindset; self-starter with ability to drive independent problem solving and develop systemic solutions
List of Typical Skills For a Clinical Development Resume
1
Skills For Clinical Development Manager Resume
- Strong communication (both verbal and written) and language skills
- Effective leadership, people management, communication skills and a team-oriented style area essential
- Experience working with physicians in an operating room or endoscopy room environment and proven clinical credibility
- Problem solving, analytical and communication skills
- Proven experience in leading a global R&D registration program is required for late development assignments
- Proven success in clinical marketing within an IVD industry Top 10 Company (0-5yrs), ideally with 2yrs’s experience within immunoassay segments
2
Skills For Clinical Development Specialist Resume
- Represent Sarah Cannon to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
- Advanced presentation and program design skills
- Demonstrated, hands-on scientific and clinical development experience
- Demonstrated hands-on scientific and clinical development experience
- Actively promote and utilize the skills and contributions of others within the project and line
3
Skills For Clinical Development Liaison Resume
- Demonstrated ability to enhance/improve customer experience
- Helping to improve the teams’ skill-sets. (50%)
- Excellent understanding of imaging hardware or software, including the ability to understand complex imaging systems
- Proven success recognizing critical issues and driving them to closure by taking coordinated action
- Good knowledge and understanding of clinical trial design and running late stage clinical trials
- Experience of working at a CRO or managing studies outsourced to CROs
- Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
- SQL programming experience in an academic or professional setting
- Build a strong understanding of data operations within a healthcare organization through interviews, training, and webinars
4
Skills For Clinical Development Engineer Resume
- Experience writing reports
- Min 6 years of experience working in the medical device industry with extensive knowledge of anatomy and clinical language proficiency
- Clinical training and/or applicable clinical research experience
- Good interpersonal relationship building/maintenance
- Good understanding of Italian healthcare environment, clinical and laboratory customer needs, and IVD sales process
- Experience communicating scientific data (verbal and written
- Proven track record of working with investigators, external experts, Contract Research Organizations and vendors
- Experience managing drug discovery or translational medicine activities
- Participation in and clinical validation of the newly developed projects. Verify all workflows of the newly developed product, posing as an end-user
5
Skills For Senior Clinical Development Manager Resume
- Effective interaction with and influence on key external decision makers (e.g., regulatory authorities, medical experts, pricing and reimbursement bodies)
- Strong work ethic; willingness to accept high levels of personal responsibility and commitment; initiative; perseverance
- Experience with design controls and product development activities in a medical device industry
- Consistently shows dedication or strong work-ethic to help meet aggressive timelines when necessary
- Ensure contracted nurses are appropriately trained on product line prior to deployment for customer in-service programs and maintain required training records
6
Skills For Clinical Development Consultant Resume
- Experience with regulatory agency standards, such as OSHA, IDPH, and DNV
- Leadership/charge experience highly desired
- Early phase oncology clinical development experience
- Demonstrates the ability to develop self and others by providing coaching and constructive feedback to reports, peers, and managers
- Experience in external stakeholder/partner relationship management and communication
7
Skills For Associate Director, Lean Clinical Development Resume
- Experience in the pharmaceutical industry or in a CRO environment in the clinical development process
- Oncology clinical development experience
- Clinical development experience across all phases of development (I-IV)
- Demonstrated strategic agility & broad business acumen
- Demonstrated leadership behaviors with ability to accept
- Strong knowledge in country regulatory guidelines/requirements
8
Skills For Director of Clinical Development Resume
- Experience in inflammation drug development
- Be relentless in Quality: Your attention to details leads to a delightful user experience
- Proven ability in clinical research methods
- Potential exposure to hazardous physical, chemical, radiological and biological agents, loud noise, and strong magnetic fields
- Researching, benchmarking, analyzing data, and making recommendations
- Working with global engineering on end to end solutions by providing clinical input from customers
- Applying knowledge of clinical MR needs to guide definition and development of new imaging and post-processing techniques
- Identifying and capturing key learnings, savings, streamlining opportunities
- Providing clinical support for the development of Magnetic Resonance Imaging products
9
Skills For Executive Director / VP, Clinical Development Resume
- Establishing key performance indicators related to existing and/or new processes
- Coordinating and organizing Corporate Development and Clinical Development Research Activities
- Defining department goals, strategies, benchmarks and action plans
- Prototyping tools to represent design
- Evaluating performance and quality of new features by designing & optimizing protocols, and traveling to partner sites for installation and testing
- Applying knowledge of clinical MR needs to guide definition and development of new hardware, new imaging and post-processing techniques
- Supporting marketing activities, customer seminars and internal training events
- Assisting with customer complaints, investigations, and product solutions
- Work with global engineering to develop post-processing features by providing clinical input from customers
10
Skills For VP, Clinical Development, Neurology Resume
- Work with global engineering to develop post-processing features and new coil technologies by providing clinical input from customers
- Provide clinical input to support the ongoing life of existing products (ie. risk assessments, field complaints, marketing material)
- Participate in the development of usability documents and pre-launch usability testing; participate in the writing of usability reports
- Apply knowledge of clinical MR needs to guide definition and development of new imaging and post-processing techniques
- MS, Phd (Biomedical Engineering, Mechanical Engineering or equivalent field),
- Ensure all nursing and clinical staff have the tools and training needed for processes
List of Typical Responsibilities For a Clinical Development Resume
1
Responsibilities For Clinical Development Manager Resume
- Demonstrated ability to prioritize, think independently and implement timely solutions
- Effectively influence senior stakeholders
- Clearly demonstrates Novartis Values and Behaviors
- Experience as a cross-functional team leader
- Creating and maintaining cross-departmental relationships to enable leadership success
- Creating systems and processes to streamline operations
2
Responsibilities For Clinical Development Specialist Resume
- Assuming day-to-day responsibility for multiple projects and tasks
- Ensure high quality of MR post processing training delivery to the field applications teams and sales/marketing team
- Use knowledge of adult learning principles to develop appropriate training materials for employees and customers
- Function as a content expert facilitating sales training sessions as designated
- Create or innovate new applications of current and developing technologies as well as innovate new concepts
3
Responsibilities For Clinical Development Liaison Resume
- Serve as liaison to clinical marketing and research departments
- Collaborate closely with product engineering to define and assess products against clinical performance goals for product improvements
- Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries
- Knowledge & understanding of the regulatory environment
- Significant track record of global study management planning and delivery
- Proactive risk management and mitigation planning from the start of a clinical development program (IDP) till closure
4
Responsibilities For Clinical Development Engineer Resume
- Interact with the TA’s Senior Leadership Team to ensure that the eCDT’s plans are aligned with department goals and within anticipated budgets
- Innovate new solutions for data capture (eSource) and patient engagement in clinical trials that fundamentally changes the status-quo in clinical development
- Key interest areas include but not limited to: apps, devices, sensors, electronic patient reported outcomes (ePRO) and eConsent
- Proactively manage ongoing relationships with key partners (e.g. monitors vendors using fact based assessment & metrics) to drive and develop industry’s best practice, innovation, quality, and inform future outsourcing decisions
- Provides oversight for all assigned business unit (BU) projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
- Develops and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements
5
Responsibilities For Senior Clinical Development Manager Resume
- Leads ‘After Action’ reviews to capture and shares best practices
- Responsible for developing strategic and collaborative partnerships with senior Clinical Development leaders. Trusted partner to Clinical Development leadership, and works closely with them to ensure that IT fully supports Clinical Development’s scientific mission
- Oversight of local strategy including feasibility and country operational
- Accountable for local feasibility activities and approve final site selection
- Review and approve forecast, baseline and re-baseline study targets
- In partnership with the Study Accountable Person (SAP), leads ‘After Action’ reviews to capture and shares best practices
- Business Management: Site level accountability from Site Selection through Site Closeout
- Review and modify clinical and claim substantiation study protocols. Make decisions regarding data analysis to support the clinical and consumer perceived benefits of a wide range of high performance products
6
Responsibilities For Clinical Development Consultant Resume
- Hands on use of skin measurement instruments and imaging techniques, assuring collection of consistent and reliable data
- Keep up with industry publications and advances in bio-engineering methods & instrumentation for demonstrable differences in product performance
- Ensure the progress of studies to meet key milestones and timely delivery of reliable data
- Develop strong collaborative relationships with core clinical team (internal and external) and cross-functional partners in PD, R&D, Marketing and Regulatory Affairs
- Support the implementation of new systems and processes in Clinical Affairs and Product Development
7
Responsibilities For Associate Director, Lean Clinical Development Resume
- Maintain clinical documentation, study master files and projecttimelines throughout the development process
- Provides oversight for all assigned Oncology projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
- Provides oversight for all assigned Ophthalmology projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
- 10) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
- Potentially leads project cross functional team with an accompanied project manager
- Collaborate with the safety group and be jointly responsible for the clinical safety and medical monitoring activities of multiple clinical trials, and held ultimate responsibility for clinical development plans, clinical trial protocols, data analyses, clinical study reports, and other related clinical documents
8
Responsibilities For Director of Clinical Development Resume
- Contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards
- Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials
- Offer alternative coding paths and keywords based on coding expertise
- 4) Oversee/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
- Partner with Research and Pharmacology departments at Halozyme to identify and address key questions
- Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions
- Play a role in post-marketing pharmacovigilance, working in conjunction with the company’s marketed drugs call center and receiving and processing post-marketing ADR reports, including the generation of narrative and completion of Medwatch forms and the authorship of Periodic Safety Update Reports
- Serve as the external clinical “face” of the program in interactions with development partners, and leading clinical discussions at investigator meetings; protocol training meetings and advisory boards
9
Responsibilities For Executive Director / VP, Clinical Development Resume
- Leverage strategic knowledge of institution’s decision making process along with historical performance with other Lilly clinical trials to deliver mutually acceptable business solutions
- Clinical Scientist (CS)Search Jobs US
- Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders
- Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases
- Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables
- Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators’ Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders
- 2) Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- 3) Drive execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/ country medical associates if applicable
- 11) Ensure career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provide on-boarding, training, & mentoring support
10
Responsibilities For VP, Clinical Development, Neurology Resume
- Provide evidence related to development needs e.g. regulatory or evidenced based citations related to certain innovations or changes pertinent to project
- Utilize coding background and knowledge to enhance client experience
- Validate / test content for ICD-10 products
- Demonstrated work with technology assessment and use of progressive technology in healthcare environment
- Willing to work extra to complete assignments and meet deadlines
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