Project Manager Clinical Resume Sample
Jeremy Rolfson
7701 Jewell Points,
Chicago,
IL
+1 (555) 163 2078
Work Experience
Clinical Affairs Project Manager
07/2017
-
PRESENT
Dallas, TX
- Business-level oral and written English
- Knowledge of the drug development lifecycle
- Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills
- Clear written and verbal expression of ideas; an active/proactive communicator
- Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing a wide range of people in an international multi-cultural environment: natural talent at building strong positive relationships
- Used to working independently and in a team environment: flexible and adapting in a changing environment
- Provide project support for both U.S. and Outside the U.S. Clinical Trials consistent with applicable regulations, guidelines and policies
Clinical Informatics Project Manager
01/2013
-
01/2017
Philadelphia, PA
- Able to tactically execute successful clinical programs and activities
- Assists by collaborating in the developing, communicating, and building of programs that support division and company objectives
- Skillfully develops, nurtures and maintains relationships with investigators, coordinators, site staff and all members of ZOLL with whom this individual works
- Assist with adhering to study execution strategy in order to meet business objectives
- Assists in the creation and implementation of immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner
- Able to simultaneously balance multiple business, clinical, product and physician requirements
- Drive the drafting and execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans
Manager, Clinical Project Management
05/2007
-
12/2012
Dallas, TX
- Oversee and manage the serology budget of clinical sample testing for all allocated studies
- Inform Quality Assurance team on any quality deviation of sample management and clinical sample testing. Actively collect, interpret, review and document the above quality deviations for clinical sample handling or testing in the appropriate QA system
- Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
- PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences
- Experience in clinical pharmacology registration studies and supporting NDA/MAA/BLA submissions in the US and EU. Doing this in Respiratory indications would be ideal
- Coordinate with Intarcia’s clinical supply vendors to meet timelines and budgets
- Liaise with Intarcia’s internal manufacturing function to communicate clinical supply demands ensure supply
- Lead software project implementations with particular focus on the delivery of solutions within life sciences industry (Pharmaceutical, Biotechnology, Medical Devices, CRO’s, and Academic & Public Health)
- Demonstrated understanding of computer systems and software application implementation (web and/or client server) including knowledge of software development life cycle
Education
Walla Walla University
2002 - 2007
Science's Degree in Engineering
Professional Skills
- Strong experience in protocol development , writing clinical section(s) for regulatory submission
- Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
- Experience with working in the military healthcare environment and working with Essentris, AHLTA, and CHCS
- Experience with project management, including in a clinical setting
- Experience working in a project management environment. (Required)
- Experience working in a clinical research/GCP environment (Required)
- Recent experience as a Project Manager managing full life cycle clinical trials with the Oracle InForm EDC product or similar EDC product
How to write Project Manager Clinical Resume
Project Manager Clinical role is responsible for software, training, integration, procurement, auditing, oncology, reporting, manufacturing, design, research.
To write great resume for project manager clinical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Project Manager Clinical Resume
The section contact information is important in your project manager clinical 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 Project Manager Clinical Resume
The section work experience is an essential part of your project manager clinical 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 project manager clinical responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular project manager clinical position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Project Manager Clinical resume experience can include:
- Life sciences industry experience and knowledge of clinical trial process (pharmaceutical, biotech, medical device companies, CRO’s and academic & public health organizations)
- Consulting experience or Client Facing Project Management experience
- Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures
- Conduct literature searches to stay abreast of scientific knowledge and to determine evidence gaps
- Possess knowledge of Good Clinical Practice ICH/GCP and other applicable regulations
- Design - Generates creative solutions; demonstrates attention to detail
Education on a Project Manager Clinical Resume
Make sure to make education a priority on your project manager clinical resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your project manager clinical 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 Project Manager Clinical Resume
When listing skills on your project manager clinical 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 project manager clinical skills:
- Manual dexterity to operate office equipment (i.e. computers, phones, etc.)
- PMP Certification and international experience desirable
- Ideal therapeutic area experience: Autoimmunity, Dermatology, Musculoskeletal, Respiratory
- Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines
- Responsible for managing Clinical Operations resources and providing oversight to staff to achieve functional goals including
- Tracks project information including patient enrollment, monitoring visits, completion of reports, and budget
List of Typical Experience For a Project Manager Clinical Resume
1
Experience For Clinical Affairs Project Manager Resume
- Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance
- Complete all planned Quality & Compliance training within the defied deadlines
- Assist with continuous improvement activities by driving the implementation of process improvement initiatives
- Serve as liaison with HCP in clinical consulting activities
- Responsible for leading pre-market clinical research activities
- Assists with site qualification, activation, monitoring and close-out activities and reports as necessary
- Actively involved in Research process improvement activities/projects
2
Experience For Clinical Informatics Project Manager Resume
- Actively involved in Corrective and/or Preventive actions tied to Research process
- Educate GEHC research teams of Good Clinical Practice guidelines, GEHC Research Management Procedure and applicable laws and regulations as they apply to research study
- Effectively and succinctly communicate MACA organization mission/vision and value to business
- Aware of comply with good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Identify and report and quality or compliance concerns and take immediate corrective action as required
- Direct or indirect expert clinical review of Scientific Evidence including Clinical Evaluation Reports, Post Market Surveillance reviews, Regulated Study Reports, Evidence Dossiers, and internal publications
- Involvement in industry advocacy and industry trade association activities related to PMS and provide updates to management on policies and trends
- Works with third party HCPs for adverse event adjudication of regulated clinical trials
3
Experience For Project Manager, Clinical Trials Resume
- Conducts focused research and prepares educational/informational presentations to educate cross functional stakeholders as required; conducts data analysis
- Serve as clinical reviewer of Study Protocols, as required
- Fulfill unsolicited requests and other administrative functions
- Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives
- Liaise with external vendors and sites to negotiate contracts and budgets
- Track study progress and provide status report on a weekly basis
- Organize and lead major study meetings and activities
4
Experience For Manager, Clinical Project Management Resume
- Identify risks and escalate to key stakeholders as necessary
- Collaborate and mentor junior clinical project manager(s) and clinical research associates
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
- Critically appraise scientific literature and write clinical summaries to assist research efforts and in development of clinical strategies and clinical investigational protocols
- Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiatives
- Previous experience implementing, supporting and managing premarket device trials
- Basic understanding of statistics, statistical methods, and design of experiment is a requirement
5
Experience For Clinical Trial Project Manager Resume
- Ensure timely completion of case report forms and queries at clinical centers within timelines determined by Clinical Director by tracking visits and reports
- Contribute to the development of study documents such as study manuals, worksheets, etc
- Track budget approvals and site payments
- Responsibility for Device shipment and Device accountability
- Interface with Data Management and EDC to generate reports and track data collection, query resolution
- Ensures protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up
6
Experience For Project Manager, Clinical Innovations Resume
- Oversee IRB/EC/CA submissions and renewals
- Oversee site contracts, payment schedules and payments
- Lead and perform clinical monitoring activities as needed to ensure compliance with the investigational protocol, good clinical practices and appropriate regulations
- Lead activities performed by Contract Research Organizations (i.e. CROs, core labs)
- Conduct audits of CROs and other outside vendors as necessary
- Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, informed consents, clinical trial agreements, monitoring plan), organizing IRB/EC submissions with follow thorough to ensure successful outcome
List of Typical Skills For a Project Manager Clinical Resume
1
Skills For Clinical Affairs Project Manager Resume
- Analytical – Ability to analyze complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction
- Experience in customer interaction / consultation for example as an IT Consultant at a Corporate IT company
- Experience in the Oncology domain
- Experience with Informatics systems
- Project manage clinical testing of the solution at existing and new sites to further build clinical and financial proof-points for the solution
- Exposure to highly confidential data, including protected health information, requires extreme discretion
2
Skills For Clinical Informatics Project Manager Resume
- Basic understanding of GMP, GLP, GCP-ICH and/or GCLP guidelines. Knowledge of product development processes, preferably in biologics and/or vaccines
- Track record of successfully managing multiple concurrent complex global phase I and IIa, multi-country, multi-site clinical trials
- A solutions focused, methodical approach in driving business results
- Collaborates with laboratory Supervisors and staff regarding specimen requirements
- Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions
- Written Communication – Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature
- Organizational Support - Supports organization's goals and values
- Adaptability & Dependability – Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals
3
Skills For Project Manager, Clinical Trials Resume
- Fast paced office and clinical setting
- Frequent, daily use of computer, telephone, fax machine
- Occasional early or late meetings to accommodate schedules
- Occasional travel to other Partner’s locations in greater Boston area
- Driver’s licence and able to travel (15%)
4
Skills For Manager, Clinical Project Management Resume
- Firm understanding of the research process including but not limited to; the development of protocol, implementation of a successful research project, and management of RA’s using project plans and coordinating teamwork assignments in the field
- Balance customer expectations with project reality
- Travel up to 25% of time of job related responsibilities
- Readiness to travel internationally and domestically as required
- Travel requirements estimated between 10-15%
- Self-motivated and keen ability to multi-task
- Supervise clinical research associates (CRA) and other employees in the completion of tasks and projects; train and mentor new employees; and serve as a resource for newly hired CRAs
- Conduct data reviews; prepare data summaries; create the clinical sections of regulatory submissions; strategize and/or coordinate responses to regulatory agencies’ questions regarding the clinical study
5
Skills For Clinical Trial Project Manager Resume
- Performing group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications
- Clear written and verbal expression of ideas, a proactive communicator
- Well-developed interpersonal skills with a proven track record of successfully interacting with and influencing a wide range of people, building strong positive relationships
- Energetic, self-motivated with the ability to drive and lead business activity
- Prepares laboratory services specifications documents to capture customer requirements
- Negotiates and prepares project schedules; communicate timelines to staff
- Leads project team meetings and conference calls with customers
- Develops appropriate sample procurement and transport procedures
6
Skills For Project Manager, Clinical Innovations Resume
- Trains staff on project specific procedures
- Work closely with clinical staff at hospital(s) to tailor offering to customer needs. This requires engagement with clinicians as well as hospital IT staff on a day-to-day basis
- Work closely with clinical staff at hospital(s) to elicit solution requirements
- Project lead the implementation of the solution at new customer/pilot sites on the ground – set-up of working teams at Philips and customer side(s) to ensure smooth and timely implementation of the solution
- Project manage ongoing collaboration and relationship with existing and new customers on a day-to-day basis, acting as bridge between Oncology Informatics product development and Marketing team based in Israel and physicians / IT staff at the customer site – this includes work on solution improvements
7
Skills For Senior Clinical Trial Project Manager Resume
- Closely collaborate with and support transition of customer management activities to the Benelux market organization
- Contributes to the development and implementation of the OCA strategic imperatives related to clinical business focus area identified each year through the HLAC
- Uses data collection model in order to collect data, analyze, and synthesize the themes related to structural, functional, and cultural that enable the successful implementation and scaling
- Leads the implementation of assigned OCA strategic imperatives through the successive phases, ensuring the identification and follow up of key issues and barriers related to implementation
- Operational responsibility for ongoing clinical studies including fiscal oversight, study timelines through completion of the clinical study report
- Direction, planning and initiation of clinical studies
- Oversight of planning, execution and interpretation of clinical studies in compliance with appropriate regulatory and medical standards
8
Skills For Project Manager Quoting Clinical Trials Resume
- Summarizes and presents results of analyses and implementation in reports, notes, spreadsheets, charts and presentations
- Integration of subject matter experts into the clinical study processes
- Direct the development of written documents, such as: clinical study protocols, clinical study reports, abstracts, peer-reviewed literature, and other relevant documents
- Assures the organization of investigator meetings, data monitoring committee meetings, steering committee meetings, as appropriate
- Interface with study team members on an ongoing basis and provides guidance and direction on clinical trial issues, monitoring issues
- Assesses feasibility of incoming research proposals
9
Skills For Clinical Trial Transparency Project Manager Resume
- Responsible for creation and tracking of study budget as well as site budgets, payments and contracts
- Develops relationships with investigators and key opinion leaders
- Set- up and coordination of all activities for service consultants/CRO’s
- Develops Informed Consent Forms, data collection tools and other study specific documents necessary for the appropriate implementation and conduct of clinical studies
- Assures the creation of study specific monitoring and communication plans and updates as appropriate
- Responsible for the identification of sites and Investigators
- Oversees and ensures timely, accurate collection of (Serious) Adverse Events, (S)ADEs and/or complaint reports and follow up in close cooperation with the Clinical Safety Department
- Participates in the development of departmental procedures, demonstrating in-depth knowledge of clinical trial processes
- Prevents, identifies, resolves and/or escalates issues identified through analysis of study data, trends and reports
10
Skills For Senior Clinical Affairs Project Manager Resume
- Plan, implement and drive all aspects of clinical studies in compliance with GCP (Global Clinical Practice) the RMP (Research Management Procedure) Work Instructions, Corporate Policies, Guidelines and internal Standards
- Manage cross-functional team, facilitating the team’s ability to fulfill their responsibilities in accordance with project specifications and regulatory, GCP and GEHC requirements
- Manage day-to day operational aspects of assigned projects including third-party vendor activities
- Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects
- Responsible for the timely and accurate completion of project documentation, such as protocols, amendments, case report forms and study report, stored appropriately and audit-ready
- Develop and maintain close working relationship with Research Manager to ensure client satisfaction, operational and customer service excellence
- Manager, maintain and accurately forecast study team requirements, clinical project subject enrollment and timelines, ensuring high level of data and image quality
- Ensures overall regulatory compliance of investigational sites with applicable regulations
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