Biometrics Project Manager

Company
Synteract
Location
United States
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
28754
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Biometrics Project Manager

US - Remote

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to life TM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

The Biometrics Project Manager (PM) is responsible for the overall coordination and management of biometrics projects; from small single service projects (e.g., data management, Biostatistics etc.) to large portions of multi-service, more-complex studies. The Sr. Biometrics PM leads technical teams, works with technical leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the Sr. Biometrics PM is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction. The role is also responsible for working with relevant operational areas to recognize change order instances and collaborate with Business Development and proposals teams to create required change orders to be presented to clients for review and approval.

Specific tasks would include:
  • Primary interface with client representatives, third party CROs, external data vendors, as well as staff members in the Biometrics departments to ensure the timely initiation, conduct and completion of clinical trials.
  • Drives efficient and high quality technical data delivery, working closely with Data Management, Biostatistics and Programming, Medical Writing, and other operational groups as relevant, on various clinical projects, triaging issues, risks and performance with data delivery through systems and
    technology.
  • Evaluates and manages project milestones. Takes corrective action when necessary to maintain alignment with client expectations.
  • Supports data delivery and technical solution initiatives for Biometrics, bridging activities, meetings, discussions or support of other technology based initiatives.
  • Participates is bid and proposal development.
  • Attends and presents at client bid defense meetings.
  • Interacts with clients, third party CRO representatives and external company vendors to ensure that all contractual obligations are met.
  • Manages sponsor expectations with regards to scope of work and deliverables. Tracks scope changes and coordinates with necessary parties
    to obtain approval for change orders.
  • Identifies potential bottlenecks and/or delays; develops and executes contingency plans in order to keep the project on schedule.
  • Works with relevant operational areas to ensure adequate resources are assigned on projects.
  • Develops Project Management Plan to include timeline and milestones.
  • Manages timelines for assigned protocol(s) and ensures that all applicable Biometrics staff are aware and on target for deliverables. Ensures efficient cross functional handoffs.
  • Coordinates client project team meetings, including development of meeting agendas and minutes.
  • Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests.
  • Owns and manages the project budget throughout the duration of the project, and collaborates with operational leads to develop out of
    scope documentation and costs as required.
  • Manages the project trial master files.
  • Leads presentation at executive project reviews and is accountable for action item follow up.
  • Works closely with his/her manager to ensure the timely delivery or completion of project associated tasks.
  • Assists with the development of study specific training and other requirements for internal and external staff, as appropriate.
  • Participates in Synteract and Biometrics initiatives (e.g. process development/improvement, technology vendor selections)
  • Develops tools to improve job function (e.g. PM checklist, helpful training for Biometrics Project Managers).

Qualifications
  • Bachelor / Masters degree in Math, Life Sciences, Nursing or a related field of study
  • Minimum 5 years applicable industry experience.
  • 3-5 years of experience as a Database Manager, Biostatistician, Clinical Programmer or Technical data build/review role in a CRO.
  • Demonstrated leadership experience in a Biometrics technical position; experience leading multiple studies simultaneously.
  • Some Project Management and Project Finance experience strongly preferred.
  • Industry experience in Data Management, programming or Biostatistics to an extent that ensures full awareness of Biometrics practices in clinical research
  • Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements.
  • Regulatory submission knowledge and/or experience preferred.


This job excludes Colorado applicants.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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