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Job Details

Associate Project Manager - Labs - Biospecimen Tracking and Reconciliation

Company name
Pharmaceutical Product Development, LLC.

Location
Seattle, WA

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Associate Project Manager - Labs - Biospecimen Tracking and Reconciliation','147046','!*!EXPECT MORE FROM YOUR CAREEREXPECT PPDPPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD. As an Associate Project Manager you will be primarily responsible for tracking a complex array of biospecimens for high profile clinical trials in clinical pharmacology, hematology/oncology, inflammation/immunology or immuno‐oncology.1. Carefully manage biospecimen accountability, chain of custody and quality.2. Utilize software tools such as Labmatrix or related biospecimen management system to track biospecimens, identify discrepancies, verify and document consent and ensure compliant utilization of biospecimens by following written procedures.3. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.4. Provide regular reports and summaries of biospecimen tracking activity.Items to Note:Typical Daily Work schedule (start/end times) = Candidates must be flexible to work hours that will support EU, East & West coast timezones, within 40 hrs/week. Weekend work not required. 100% onsite work.IMPORTANT NOTE: Candidates for this position must have proven experience in tracking clinical trial biospecimens including but not limited to 1) biospecimens from sites to central lab to third party labs and 2) biospecimens from sites directly to third party labs. The candidate should have experience incross‐checking and resolving biospecimen attributes between EDC/IVR and vendor databases, commonly referred to as header reconciliation.Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you chose to Be with PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves. Join PPD in our relentless pursuit of excellence - apply now!','!*!Education and Experience:

Bachelor's degree in medical technology, pharmaceutical science, biology, other health related field or equivalent experience that provides the skills and knowledge required to perform the job

Minimum of 1 year experience in a clinical trials environment or similar field

Minimum of 1 years experience in a project management capacity

Or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities

2‐4 years clinical trial biospecimen managementexperience in a clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment.Ability to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs).Demonstrated understanding of basic principles in clinical research and biospecimen processing procedures involving blood and tumor biopsies.Experience in working with clinical trial protocols and informed consent.Detailed knowledge and experience in case report forms, EDC listings, central laboratories databases and query resolutionAwareness of global biobanking issues; basic experience in working in organizations adhering to quality standards.Experience with Labmatrix, GSS or related sample management system is a plus.Knowledge of at least one data management system experience with SAS data sets and conversion procedures is a plus.Knowledge of MS Office program suite required.Intermediate‐level Excel is a plus.Professional inter‐personal skills and excellent oral/written communication.Leadership skills in conflict management, facilitation and negotiation a plus.Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines

Good computer skills

General knowledge of clinical trial processes and programs

Strong attention to detail and problem solving skills

Effectively conduct oral presentations

Demonstrated experience in identification and resolution of technical problems in a professional environment

Ability to maintain a high degree of confidentiality with clinical teams

Ability to attain, maintain and apply a working knowledge of applicable Procedural Documents

Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

Working Conditions:

Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

Occasional drives to site locations, occasional domestic travel. 

Exposure to biological fluids with potential exposure to infectious organisms.

Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

Personal protective equipment required such as protective eyewear, garments and gloves. 

Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Demands:

Ability to work in an upright and /or stationary position for 6-8 hours per day.  

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.  

Occasional mobility needed.

Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.    

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

Frequently interacts with others to obtain or relate information to diverse groups.  

Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.  Requires multiple periods of intense concentration.

PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.','Lab Operations','North America-United States-Washington-Seattle','','','false','','false','Associate Project Manager - Labs - Biospecimen Tracking and Reconciliation

Company info

Pharmaceutical Product Development, LLC.
Website : http://www.ppdi.com/

Company Profile
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

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