Project Manager - Biomarker Senior Sample Operations Lead

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.

Translates protocol-level sample needs into clearly defined deliverables in support of study start up with clinical sites and laboratory vendors. Understands team needs and communicates alignment with program testing strategy and escalates to Sample Strategy Analyst for the TA where there are areas of departure from established standards or recommended guidelines.

* Partners across the protocol team to ensure sample management needs are clearly understood and able to be contracted in accordance with client policy. * Develops sample collection instructions for sites as needed to ensure clarity, quality and promote compliance. Supports the site/investigator training for proper collection techniques, time point requirements, and sample handling to ensure viability and data reliability. * Partners with clinical teams, Sample Strategy Analysts, vendor management, outsourcing management and global procurement to drive the strategic client position to enhance the value of preferred partners’ capabilities to client through early engagement with internal teams as well as our preferred labs, cross-organizational discourse and planning transparency. * Supports escalation of sample management concerns during the execution of a protocol. Ensures all issues are logged, advises on mitigation and remediation of issues, escalates issues and drives to closure in support of team goals and timelines. * Supports biomarker and pharmacokinetic/immunogenicity sample tracking; assessing requirements, establishing operational level agreements for service, generating reports and trackers, collaborating with internal and external partners for clarification and escalating issues to the clinical team. * Supports the creation of documentation related to sampling strategies and updates at each DP (or ad hoc as necessitated by scope/nature of changes to previously established standards) by providing valuable assistance as scribe for critical strategy meetings including internal and external engagement meetings. * Demonstrates good communication and interpersonal skills; leverages those competencies to ensure continuous progress of internal and external teams thus moving issues to resolution. * Actively maintains a CSS&O; Book of Work for his/her respective therapeutic area(s); ensuring protocol status and resource demand are updated for management assessment on a monthly basis. * Maintain personal monthly time metrics in support of protocol startup and execution in order to aid senior management review of overall drug development costs. * Participate as internal SME in Due Diligence efforts for third-party Specialty Labs to ensure that specialty lab operations are functioning with an appropriate internal control environment, and meeting expectations of relevant regulatory requirements as dictated by the nature of the work entrusted to their execution as required. * Serves as CSSO liaison to other strategic and process improvement initiatives affecting his/her therapeutic area(s) as required. * Fosters teamwork between client functional areas; creating a team environment based on mutual trust and respect. Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis. * Displays strong written and oral communication skills. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals with professionalism and poise.

**Education and Experience:** * Bachelor's degree in Chemistry, Biology, or related field or equivalent and relevant formal academic / vocational qualification * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience. **Knowledge, Skills and Abilities:** * Strong verbal, written and presentation skills * Minimum of 2 years Clinical Research experience required * Superior time management, planning, and organizational skills * Competent with specific computers and enterprise applications, including office productivity * Ability to program the IT system according to protocol requirements * Proven analytical skills * Demonstrated compliance with procedures and policies * Ability to perform multiple tasks effectively in a stressful environment * Extensive knowledge and experience in Project Management * Strong client relationship management skills * Ability to work effectively with multi-level teams