Qureos Mentor

Planet Pharma

<div>
 Pay Rat Range: 31-41/hr
 
 
 <ul>
 <li>
 depending on experience
 
 
 </li>
 </ul>
 Skills Needed &ndash;
 
 
 SAP SAC Analytics Cloud
 
 
 Excel
 
 
 Medical Device
 
 
 Data Models
 
 
 Operating under general supervision, this role collaborates closely with the analytics team to extract, aggregate, and analyze data from centralized databases using SAP SAC and Excel. Responsibilities include designing and generating reports based on defined parameters, ensuring high standards through rigorous quality checks&mdash;including validating both personally authored and peer reports. The position provides robust client support by developing interactive data analysis tools and advanced statistical interpretations to enable informed decision-making. Emphasis is placed on continuous process improvement, integrating standardized and ad hoc reporting workflows to maximize efficiency and minimize workload. Data validity and consistency are maintained through thorough cross-functional verification, supporting both regulatory alignment and internal monitoring. Additional duties involve educating stakeholders about the complexities of complaint and sales distribution data, executing sophisticated database queries to fulfill global safety information requests, and preparing regulatory and post-market reports with limited supervision. Effective cross-departmental collaboration and strategic deadline negotiation ensure the timely delivery of urgent and non-urgent reporting needs, optimizing both customer satisfaction and organizational performance.
 
 
 <ul>
 <li>
 CO/NYC candidates might not be considered
 </li>
 </ul>
</div>

Data Analyst II

<div>
 
 
 Role Purpose
 
 
 
 Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
 
 
 
 Essential Job Functions
 
 
 
 Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
 
 
 Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
 
 
 Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
 
 
 Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
 
 
 Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&amp;D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.
 
 
 Assist with any site remediation activities, as applicable
 
 
 Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
 
 
 Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
 
 
 
 Required
 
 
 
 Bachelor's Degree or Equivalent Life Sciences or Nursing
 
 
 3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
 
 
 Experience with electronic data capture.
 
 
 
 Preferred
 
 
 
 Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
 
</div>

Clinical Research Associate

<div>
 
 Job Summary
 
 
 
 As a valued member of our North American Sales management team, this individual will be responsible for the direct management of CMS Territory Managers (sales representatives) and Sales Associates within an assigned region.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Manages medical equipment sales activities and is responsible for planning, organizing, and implementing sales programs for the assigned region.
 </li>
 <li>
 Engages with key accounts and builds relationships throughout the region.
 </li>
 <li>
 Responsible for consistently meeting or exceeding region performance objectives, including order counts, booked revenue quotas and profit.
 </li>
 <li>
 Maintain a positive attitude, control discounts and expenses to contribute positively to our profitability.
 </li>
 <li>
 Hires, educates, retains and promotes talented sales professionals.
 </li>
 <li>
 Foster a team environment within your region. Lead by example, motivate and inspire your team.
 </li>
 <li>
 Communicate, implement, and monitor the CMS Strategic Plan.
 </li>
 <li>
 Develop Territory Managers through coaching and positive reinforcement.
 </li>
 <li>
 Spend an average of four days per week working in the field with your TM''s.
 </li>
 <li>
 Manage and assess Territory Managers adherence with regional expectations to improve performance. Become a company expert and resource on both internal and competitive landscape.
 </li>
 <li>
 Responsible for field reinforcement of products and positioning strategy.
 </li>
 <li>
 Represent company in a professional and ethical manner.
 </li>
 <li>
 Communicate openly and share information with others.
 </li>
 <li>
 Analyze and report on trends that you observe within your region.
 </li>
 <li>
 Directly supervises Territory Managers in the field. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
 </li>
 <li>
 Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
 
 
 </li>
 </ul>
 
 Required/Preferred Education And Experience
 
 
 
 <ul>
 <li>
 Bachelor's Degree required
 </li>
 <li>
 At least three (3) years of field sales experience &ndash; client focus within cardiology, medical device and/or pharma industries required
 </li>
 <li>
 Five or more years of experience in medical equipment sales management &ndash; preferably cardiology. Demonstrated business acumen within the medical industry.
 
 
 </li>
 </ul>
 
 Knowledge, Skills And Abilities
 
 
 
 <ul>
 <li>
 Proven sales leadership.
 </li>
 <li>
 A valid driver&rsquo;s license
 
 
 </li>
 </ul>
 
 Travel Requirements
 
 
 
 <ul>
 <li>
 60% This job is a field-based position and requires that you reside within the assigned Region. Employee will be responsible for working daily in hospitals, doctors&rsquo; offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs. This position will require at least 60% travel. Travel may be outside the local area and overnight and could be for an extended period.
 
 
 </li>
 </ul>
 
 Physical Demands
 
 
 
 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
 <ul>
 <li>
 Standing - Occasionally
 </li>
 <li>
 Walking - Occasionally
 </li>
 <li>
 Sitting - Occasionally
 </li>
 <li>
 Lifting - Occasionally
 </li>
 <li>
 Talking - Occasionally
 </li>
 <li>
 Hearing - Occasionally
 </li>
 </ul>
</div>

Regional Manager - Birmingham, AL

<div>
 Pay rate: 23/hr
 
 
 
 Basic Function
 
 
 
 This position contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required preformulation, formulation and process activities.
 
 
 
 Specific Activities, And Responsibilities
 
 
 
 <ul>
 <li>
 Responsibility for the maintenance and cleaning of laboratory instruments and equipment; maintaining the laboratory in a clean and organized state
 </li>
 <li>
 Maintains inventory of glassware, chemicals, reagents, raw materials/excipients, consumables, media and materials needed for preformulation and formulation activities
 </li>
 <li>
 Disposes of hazardous waste according to environmental regulations and company/ departmental procedures.
 </li>
 <li>
 Receive, label and store receipts of solvents and other analytical reagents.
 </li>
 <li>
 Prepares reagents, standards, media, etc. needed for analysis
 </li>
 <li>
 Sets up, uses and cleans isolator
 </li>
 <li>
 Supports preparation of solubility, compatibility samples
 </li>
 <li>
 Sets up, operates and cleans mixers, laboratory scale encapsulation machine, coating pan and/or other equipment
 </li>
 <li>
 Prepares laboratory fill mixes
 </li>
 <li>
 Prepares gel swatches
 </li>
 <li>
 Executes drying studies
 </li>
 <li>
 Washes, inspects and packages laboratory batches
 </li>
 <li>
 Performs fill moisture, water activity, hardness, fill and shell weight, rheology, burst strength, impact/drop testing, disintegration and/or other testing
 </li>
 <li>
 Records the results in approved notebooks, batch records, reports and logbooks.
 </li>
 <li>
 Washes glassware used to perform analysis if needed
 </li>
 <li>
 Ships samples to customers (animal PK samples, airfills, etc.) as needed
 </li>
 <li>
 Files and maintains laboratory records
 </li>
 <li>
 May provide training to new or existing personnel
 </li>
 <li>
 Required to read and execute departmental guidance and SOPs.
 </li>
 <li>
 Performs other miscellaneous duties as required
 </li>
 <li>
 May be required to work with highly potent compounds, hormones.
 
 
 </li>
 </ul>
 
 Knowledge Requirements
 
 
 
 Education or Equivalent:
 
 
 <ul>
 <li>
 Requires High School education, and preferably with some college course work in related sciences.
 </li>
 <li>
 Prefer prior experience in a laboratory setting.
 </li>
 <li>
 Must possess good interpersonal skills.
 </li>
 <li>
 Ability to effectively communicate with co-workers.
 </li>
 <li>
 Good organizational skills required
 
 
 </li>
 </ul>
 
 Knowledge/Skills Requirements
 
 
 
 <ul>
 <li>
 Must have accurate and legible documentation skills
 </li>
 <li>
 Knowledge of software applications (MS Word and Excel)
 </li>
 <li>
 Experience with analytical equipment (balances) preferred
 </li>
 <li>
 Required to use laboratory equipment
 
 
 </li>
 </ul>
 
 Physical/Mental Requirements
 
 
 
 <ul>
 <li>
 Ability to work effectively under pressure to meet deadlines
 </li>
 <li>
 Ability to stand, walk and reach regularly.
 </li>
 <li>
 Individual is required to sit, stand, walk, stoop, kneel, crouch regularly and lift to 40 pounds; no lifting greater than 44.09 pounds without assistance.
 </li>
 <li>
 Can access laboratory, office areas and manufacturing with ability to comply with gowning requirements.
 </li>
 <li>
 Can use required laboratory and office equipment
 </li>
 <li>
 Vision requirements include reading of written documents and frequent use of a computer monitor.
 </li>
 <li>
 Vision requirements include ability to differentiate color, have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.
 </li>
 </ul>
</div>

Lab Technician I

<div>
 
 Job Description
 
 
 
 
 The Opportunity:
 
 Clinical Trial Assistant I
 
 
 This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
 </li>
 <li>
 Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
 </li>
 <li>
 Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
 </li>
 <li>
 Assist project team(s) with sample management and generate trial progress tracking systems.
 </li>
 <li>
 Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
 </li>
 <li>
 Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
 </li>
 <li>
 Gather investigator and site information to support study start-up, maintenance, and close-out activities.
 </li>
 <li>
 Assist in contacting investigator sites to provide study specific information.
 </li>
 <li>
 May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
 </li>
 <li>
 Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
 </li>
 <li>
 Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
 </li>
 <li>
 Support other clinical operations activities as appropriate.
 
 
 </li>
 </ul>
 
 Required Skills, Experience And Education
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in biological sciences or health-related field required.
 </li>
 <li>
 1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
 </li>
 <li>
 Has knowledge of GCP ICH Guidelines .
 </li>
 <li>
 Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
 </li>
 <li>
 Excellent written/verbal communication and interpersonal skills.
 </li>
 <li>
 Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
 </li>
 <li>
 Travel may be required (~10%).
 
 
 </li>
 </ul>
 
 Preferred Skills
 
 
 
 <ul>
 <li>
 Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
 </li>
 <li>
 Oncology experience preferred.
 </li>
 <li>
 Attention to detail.
 
 </li>
 </ul>
 The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
 
</div>

Clinical Trial Assistant I - CTA