Manager, Clinical Data Management Resume Sample
Santa Stracke
793 Howard Fords,
Dallas,
TX
+1 (555) 198 9635
Work Experience
Manager, Clinical Data Management
02/2017
-
PRESENT
Chicago, IL
- Working with sales and marketing to promote data management services and expand the service offering
- Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database
- Manage all aspects of the clinical trial data management process from study start-up to database lock for Electronic Data Capture (EDC) trials
- Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects
- Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables
- Monitor timelines and ensures that clinical data management deadlines are met with quality
- Perform UAT for database and test according to UAT Plan
Senior Manager, Clinical Data Management
05/2011
-
10/2016
Detroit, MI
- Specify requirements for data management documentation, electronic and manual edit checks created by CRO
- Review and approve electronic and manual edit checks created by CRO
- Review and approve data management documentation created and maintained by CRO
- Create and maintain electronic and manual edit check specifications for internal studies
- Create and maintain data management documentation for internal studies
- Review and provide feedback on protocols
- Ensure adherence to data management standards
Asso Manager, Clinical Data Management
03/2006
-
03/2011
San Francisco, CA
- Provide written and/or verbal status reports to department and project team
- Provide data management input to Requests for Proposal
- Review vendor proposals, work orders and contracts
- Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements
- Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
- Investigate, evaluate and implement new technology solutions
- Experience with eSource
- Electronic data capture/reporting experience (Rave, JReview, BOXI)and working knowledge of SDTM and C-DASH principles desirable
Education
Harvard University
2002 - 2006
Bachelor's Degree in Technical
Professional Skills
- Excellent planning and organizational skills; ability to prioritize work
- Good organizational skills, problem-solving abilities, time management skills and initiative
- Excellent communication skills and (in)direct line management experience and/or knowledge
- Demonstrated project management and vendor oversight skills, including pro-active project planning
- Demonstrated leadership, management, supervisory, and collaboration skills across functions to drive effective and efficient Clinical Data Management practices
- Demonstrated leadership, management, supervisory and collaboration skills across functions to drive effective and efficient clinical data management practices
- Allocate resources based on individual skills, competencies, and availability Involvement in the development of training programs
How to write Manager, Clinical Data Management Resume
Manager, Clinical Data Management role is responsible for travel, planning, english, oncology, training, integration, database, auditing, security, java.
To write great resume for manager, clinical data management job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Clinical Data Management Resume
The section contact information is important in your manager, clinical data management 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 Manager, Clinical Data Management Resume
The section work experience is an essential part of your manager, clinical data management 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 manager, clinical data management responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, clinical data management position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Clinical Data Management resume experience can include:
- Programming experience with SAS, SQL, XML and/or JAVA
- Learn, create and maintain a working knowledge of regulatory guidelines, Good Clinical Practices and Standard Operating Procedures
- Experience with Medidata RAVE including database build, edit check programming, and data extraction
- Strong attention to detail and ability to take ownership of complex issues, ensuring resolution
- Experience with SAS programming (recommended)
- Experience with Spotfire programming (recommended)
Education on a Manager, Clinical Data Management Resume
Make sure to make education a priority on your manager, clinical data management resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, clinical data management 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 Manager, Clinical Data Management Resume
When listing skills on your manager, clinical data management 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 manager, clinical data management skills:
- Sound problem solver with good negotiating skills
- With keen attention to detail and good organisational skills
- Good written and oral communications skills in the English language
- Adept at problem solving, numerical abilities and analytical skills
- Prior experience managing vendors/CROs
- Develop strong working relationships and maintain effective communication with clients, partners and colleagues
List of Typical Experience For a Manager, Clinical Data Management Resume
1
Experience For Senior Manager, Clinical Data Management Resume
- Optimize interdisciplinary understanding and teamwork across functions to drive effective and efficient Clinical Data Management practices
- Related Clinical Data Management Experience
- Work proactively with the clinical systems lead(s) as needed to ensure effective processes and communications
- Experience with electronic data capture systems, preferably OpenClinica
- Experience in Oncology (Hematologic Cancers specifically)
- CDM experience within clinical development
- BA/BS in relevant field and 10+ years experience
- Assists in preparation and delivery of training materials, as well as advises and contributes to mentoring
2
Experience For Data Manager, Clinical Data Management Resume
- Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
- Recruitment (work with Human Resources to recruit and select high performing talent)
- Ensure efficient use of resources across the franchise to provide high quality clinical data, on time, within budget by monitoring progress and conduct of their teams respective projects. This includes all data cleaning and QC activities and partnering as appropriate with Clinical Operations, Franchise and other BSDM functions
- Be responsible for approval of data management plans and other respective data management documentation as needed
- Be a strong mentor and coach to fellow System colleagues, direct staff reports, contractors and vendors providing an environment of shared learning, quick decision making (D-A-I principles), and teamwork
3
Experience For Asso Manager, Clinical Data Management Resume
- Develops career plans for direct reports, makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities
- Provides developmental opportunities for direct reports, including challenging growth assignments. Prepares promotion recommendations. Ensures direct reports receive appropriate training and mentoring to be successful in their assignments
- Aligns others around a positive direction. Develops challenging but achievable objectives that clearly support stated organizational goals
- Conducts management and functional area meetings, contributing expertise when necessary through formal or informal presentations
- Participates in the recruitment process
- Maximizes staff effectiveness by working with direct reports to ensure a realistic workload that supports value-added work and work-life balance, estimating length and difficulty of tasks and projects, anticipating and adjusting for obstacles and setbacks, and elevating issues to the appropriate management level
- Assume specific functional leadership responsibilities for business deliverables assigned to direct reports and supervised staff on project
- Increases team and functional effectiveness by supporting functional efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts under the direction of Associate Director
- Along with other PMs and CDMs, leads the effort to improve KAI’s best practices, Standard Operating Procedures, and internal standards for data management
4
Experience For Manager Clinical Data Management Resume
- Consciously create a workplace culture that is consistent with the Company's identified mission, vision, guiding principles and values. Foster a spirit of teamwork and model the corporate values of integrity, courage and passion. Encourage openness, honesty and unity among department members
- Lead Employees by delegating responsibility and developing and managing the appropriate framework for accountability (RACI) and feedback. Empower Employees to take responsibility for their jobs and goals
- Collaborates with global and local subfunctional management teams to ensure studies and non-study tasks are adequately resourced, utilizing service provider resources as appropriate
- Direct supervision of staff including Clinical Data Managers and/or Clinical Data Reviewers
- Participate on multidisciplinary project teams as the clinical data management representative
- Lead outside vendor collaboration on transmittal of study specific data
- Develop and run data query systems, when applicable
5
Experience For Senior Manager Clinical Data Management Systems Resume
- Work with IT department to ensure successful integration of clinical study data into company systems and to properly extract information from company databases
- Develop and promote consistent data management standards through creation of DM SOPs, study guidelines, and other departmental work processes
- Supervise clinical data manager staff
- Knowledge of clinical study and data management processes from study design to data archival
- Work in a team environment with clinical monitors, biostatisticians and medical writers
- Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed
- Oversee and manage all DM related activities insourced or outsourced to DM SP as well as other third party data vendors (e.g. central and/or specialty labs, IVR vendors, etc.) from protocol concept through trial close-out and
- Participate with Clinical Operations for all trial activities, and lead all DM functional activities using established DM standards, templates and processes as applicable
6
Experience For Group Manager, Clinical Data Management Resume
- Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring compliance with industry established standards and reporting
- Work closely with other functional areas to ensure high quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc
- Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews
- Perform hiring and training activites as needed
- Manage a team of professional Data Management staff. Size of team could vary from 5+ upwards -15, depending on the
- Project level coordination and day to day oversight of Data Management tasks
- Manage vendors, and ensure appropriate resources are available to meet the demands of the assigned clinical trials
- Responsible for data management and back-end activities supporting Alkermes clinical programs from DM strategy, database start-up through database lock and CSR/submission
7
Experience For Program Manager, Clinical Data Management Resume
- Oversee data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
- Oversee key documents such as data validation specifications and programs, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc
- Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and
- Advanced knowledge of Data Management processes and systems
- Independently develop and guide team members through the development of DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
8
Experience For Manager, Clinical Data Management Resume
- Assist in hiring, training, and mentoring Clinical data associates
- Independently perform and guide team members through the data cleaning and database lock process in an efficient and timely manner
- Lead studies and guide team through DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Develop guidelines and work instructions for handling of data
- Assist in performance evaluation and career development planning for team members
- Work in conjunction with Clinical Research Associates (CRAs), Clinical Project Managers, and others on the Clinical Affairs team on Case Report Form (CRF) design process utilizing existing data form standards
- Work closely with study project team to provide clinical study support with an emphasis on site management, device management and start-up activities·In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and clinical research associates
- Provide and work with Electronic Data Capture (EDC) vendor to program CRFs and improvements to EDC
- Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner
9
Experience For Senior Manager, Clinical Data Management Resume
- Ensure Quality Control guidelines/instructions for Clinical Affairs data team
- Create and maintain Data Management Plans, including, but not limited to: CRF flow, external data handling, Serious Adverse Event (SAE) processing, coding, lock procedures, and archival procedures, collaborating with Clinical
- Act as a point person for all data related to clinical affairs group, to provide data to cross-functional departments
- Help to develop and implement automation of current processes and procedures in collaboration with Product Innovation team
- Collaborate in the creation of SOPs and Work Instructions related to data management
10
Experience For Data Manager, Clinical Data Management Resume
- Write and produce reports and queries
- Assist and support statistician with data analysis
- Experience with relational database design, general knowledge of FDA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
- Provide strategic, organizational, and operational management and guidance to the Clinical Data Management group
- Collaborate with the other SCHARP senior managers to create and implement overall organizational vision and strategic direction
- Foster and promote the long-term development of the Clinical Data Management team, work closely with the SCHARP Director, senior management team, and the CDM managers to define ways in which the team contributes to the advancement of SCHARP and to improve the operational effectiveness of the group
List of Typical Skills For a Manager, Clinical Data Management Resume
1
Skills For Senior Manager, Clinical Data Management Resume
- Demonstrate leadership skills and the ability to lead teams and motivate team members
- Communicate effectively to all levels within the organization and external partners
- Strategize to optimize resources effectively to meet timelines and deadlines
- Experience using and creating basic reports in SAS
- Experience developing and managing clinical studies with IBM Clinical Development EDC system
2
Skills For Data Manager, Clinical Data Management Resume
- Experience in working with electronic data capture tools
- Experience in working with CROs/EDC vendors for data management activities is desirable
- Attain, maintain and apply a strong working knowledge of GCPs and applicable SOPs
- Lead/approve CRF design, review and validation of the clinical database, including management of CRO activities in this area if required
- Oversee building, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
3
Skills For Asso Manager, Clinical Data Management Resume
- Demonstrated knowledge of personal computers, database structures and database management software
- Manages experienced professionals and / or subordinate management who exercise latitude and
- Able to prioritize and handle multiple tasks and studies simultaneously
- MS and 5+ years of related experience or
- Experience in the development and use of clinical data management electronic data capture products
- Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting
- Overseeing and ensuring staff is providing adequate DM services to customers
- Reviewing and providing feedback on all contracts that include Data management services to ensure DM pricing is reasonable
4
Skills For Manager Clinical Data Management Resume
- Leading and providing guidance to the team with regard to data management
- Developing and implementing departmental process improvements as needed
- Attending and presenting at organizational meetings as required
- Ensuring all project billing is completed on time and with accuracy
- Reviewing documentation and requirements for new projects and anticipating impact to data management and therapeutic area standards/processes
- Collaborating with appropriate project teams as needed to stay abreast of and changes that could affect data collection, cleaning and/or deliverables
5
Skills For Senior Manager Clinical Data Management Systems Resume
- Participating in the review and updating of company and department SOPs related to department
- Reviewing literature to stay current in the Data Management field
- Working knowledge of GCP, FDA, ICH, CDISC, etc., regulations and guidelines
- Working knowledge of CDISC, MedDRA
- Participating in the creation and modification of SOPs and WIs to support the DM department
- Ensuring all project forecasts and projections are completed on time and with accuracy
- Overseeing all data management deliverables for therapeutic area and/or modality
6
Skills For Group Manager, Clinical Data Management Resume
- Participating in sponsor meetings as requested
- Be responsible for Identification and management of data handling processes for non-CRF data, including lab and image handling
- CRO oversight for DM activities including data deliverables, contract review, meeting coordination and issue escalation
- Responsible for leading and managing the Clinical Affairs data management team
- Lead efforts co-ordinating with Medical Affairs organization as needed to facilitate data coding and safety reviews as needed
7
Skills For Program Manager, Clinical Data Management Resume
- Provide guidance to study teams and external vendors regarding the technical aspects of clinical database structure and programming
- Provide support to the Clinical Data Management group when assistance is needed in dealing with issues with internal and external clients
- Advanced technical expertise in databases, EDC platforms, data imports/integrations; SAS and/or SQL programming an asset
- This can be 4+ different product programs representing up to 7+ different Phase I and Phase II clinical trials
- Recruit and retain high performing team members
- Able to work under pressure and in a changing environment with flexibility
8
Skills For Manager, Clinical Data Management Resume
- To work with CRO, colleagues direct reports and other stakeholders. Independently working with minimal instruction required
- PMP or other project management training desired
- Ensure all projects are adequately resourced to meet project deliverables and ensuring data management tasks remain on target to project timelines
- Participate in vendor evaluation, selection, contracting, and oversight activities for Clinical Data Management
- Help set a clear vision and strategy for the Systems team, keeping the team aligned and on track to functional goals and commitments
- Provide input in the drafting of protocols, forms and data collection processes
- Generate and maintain data management-related documentation including case report forms, data management plans and edit specifications
9
Skills For Senior Manager, Clinical Data Management Resume
- Develop and perform user acceptance testing of clinical databases
- Provide study-specific training on the electronic data capture system to internal and external personnel
- Perform ongoing data review and specific reports or listings as required by Statistical Analysis Plan
- Provide CDM expertise for database set up, CRF design, and data cleaning to efficiently ensure high quality data
- Collaborate with Statistical Programming to create internal data quality checks in support of Data Management activities
- Review clinical data on an ongoing basis to ensure quality data
- State of the art understanding of data standards (CDISC, CDASH) in the clinical trial environment
- Provide leadership, training, and support to Data Managers
- Manage and evaluate the Clinical Data Management group
10
Skills For Data Manager, Clinical Data Management Resume
- Provides support for management of budget, resources, and project delivery deliverables
- Champion the use and application of Accenture s SOPs and Guidelines
- Participate in the selection process and implementation of new data management systems and tools
- Work with Director of Clinical Data Management to develop and defend proposals for future business
- Manage multiple tasks across multiple projects Perform staff evaluations
- Provide data management support on clinical trials and ensuring that clinical data management activities are conducted in accordance with regulatory and company standards
- Possess excellent communication skills in written and spoken English
List of Typical Responsibilities For a Manager, Clinical Data Management Resume
1
Responsibilities For Senior Manager, Clinical Data Management Resume
- Excellent project management and organizational leadership experience
- Experience in CDM, with at least 5 years’ management experience in a pharmaceutical, CRO, biotech or life sciences research organizations
- Excellent project management and organizational leadership and change management experience
- Experience in the development and use of commercial clinical data management systems/EDC products
- Experience in the development and use of commercial clinical data management. Systems and/or EDC products
- Agile software development certification or work experience
2
Responsibilities For Data Manager, Clinical Data Management Resume
- Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress
- Four to six years of related experience in medical device and/or pharmaceutical clinical research or health services industry
- Experience in comparable position within the pharmaceutical, biotech or CRO industry
- In clinical data and experience with EDC
- Experience in Medical Device or pharmaceutical clinical trials
- Experience in managment or a supervisory role
- Collaborates with peers, managers, and business partners to build effective team environment
- Identifies issues and recommends actions towards effective solutions
3
Responsibilities For Asso Manager, Clinical Data Management Resume
- BS and 8-10 years of related experience or
- Identify out-of-scope work and provide revised costs with supporting documentation
- Responsible for working with the Clinical Affairs team to set and meet CDM timeline benchmarks for study milestones
- Provide operational input into proposals and scope of work. Participate in proposal defences
- Creates and executes on a vision for the CDM group in line with company and department needs as well as industry standards and regulations
- Oversees, manages and develops the CDM staff; provides training and training opportunities for professional development with a commitment to maintain engagement of team members in collaboration with other department leaders
- Prioritizes, manages and contributes to EDC system development, data review and programming across multiple projects
4
Responsibilities For Manager Clinical Data Management Resume
- Constructive interaction with inter and intradepartmental team members and personnel
- Travel (domestic and international) up to 30% to other business locations, vendors or customers
- Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of
- Knowledge and experience with various clinical databases (e.g., Medidata Rave, Oracle Clinical, SAS) and key technologies (e.g., EDC, Laboratories, Imaging, IVRS/IWRS)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
- Able to manage direct staff. Ability to develop project management objectives and manage performance reviews, as needed
- Experience in CDM, of which 4 years in either a leadership role as a Team Leader/Manager for a significant clinical program, or a supervisorial role within a CDM function in a clinical research setting
5
Responsibilities For Senior Manager Clinical Data Management Systems Resume
- Advanced knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
- Advanced knowledge of FDA & ICH, GCP, GCDMP, and related clinical research regulatory requirements
- Advanced knowledge of clinical research business requirements
- In-depth knowledge of project management tools and processes are required
- Excellent written and verbal communication skills in Chinese and English. Confident in giving presentations and actively participating in meetings / conferences in both languages. Sharing best practices in soft skills and communication
6
Responsibilities For Group Manager, Clinical Data Management Resume
- Clinical research, FDA, GCP and GCDMP, and related regulatory requirements
- Knowledge of blood and marrow transplant clinical research and medical field
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment
- Takes an active role in projects as assigned by supervisor and interacts with key partners as appropriate
- Subject Matter Expert / Point of Contact
- Proficient with MS Word, Excel and Outlook
7
Responsibilities For Program Manager, Clinical Data Management Resume
- Interface directly with the EDC vendor to oversee study database development
- Provides a high level of technical and relational contributions
- Develops relationships to build trust with team members and business partners to achieve goals
- Independence in their assignments. Often heads one or more sections or a small department
- Expert knowledge of the requirements of 21 CFR part 11
- Expert knowledge of the requirements of GCP
8
Responsibilities For Manager, Clinical Data Management Resume
- Expert knowledge of best practices for EDC and clinical data base systems
- Work in cross functional teams and matrixed organizations
- Consistently achieves individual goals set with manager
- Responsible for operational execution of CDM responsibilities for Agensys Clinical Trial Programs
- Data management technology
- Possess quality mindset
- Manages team dynamics
9
Responsibilities For Senior Manager, Clinical Data Management Resume
- Be an avid, contributing member of the Global Site Operations Clinical Systems Leadership Team setting strategic course to future technology and innovation adoption, defining functional goals, communicating and addressing team risks, providing technical subject matter expertise, and having a strong sense of ownership over the advancement of the clinical trial portfolio and projects
- Use the performance management and individual development planning process to provide an overall context and framework which encourages Employee contribution. Provide effective on-going coaching and performance feedback through Employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, when necessary. Maintain transparent communication
- Strong sense of prioritization and of making timely adjustments. Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and performance driven, sense of urgency. Team spirit, strong work ethic, and good self-awareness. Analyzes, provides recommendations and makes decisions with direction from manager. Strong leadership capabilities
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