Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.

General Summary

The Project Manager of Advarra Consulting has the responsibility, as assigned, to serve in a team leadership role and operate under the direction of a Managing Director, Director or Associate Director, or as a client liaison as assigned and provide consultancy services as an individual or as part of a larger GXP or Consulting Team for Advarra Consulting Client Projects.

The GXP Service Line generally includes Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), Good Pharmacovigilance Practice (GVP), collectively known as GXP. The other COEs including Regulatory, Clinical and Institutional Research generally includes regulatory strategy, regulatory compliance, regulatory affairs, protocol development, and medical writing business opportunities in the human subject research market and broader life sciences field. All COE service lines may also include Information Technology (IT), medical device and other support and may expand or change based on business needs.

The Project Manager professional applies working knowledge and expertise in project management, clinical research, quality assurance, regulatory affairs and other diverse areas, as assigned, by the management team to effectively manage services and project deliverables to Clients.

Job Duties and Responsibilities

• The Project Manager must have the ability to work independently as well as communicate well with other professionals.
• He or she must have strong planning skills and have a working knowledge of MS Project or a similar planning tool. The ability to develop a plan from ambiguity is essential for the role.
• He or she must have the ability to lead a team to success with the resources available at the time.
• He or she must have strong written and verbal communication abilities and highly effective interpersonal skills. Excellent organization and ability to focus on detail are also essential.
• Project Manager must also possess effective leadership abilities.
• He or she must make sure all individuals are up to date on all contacted services, and deliverables.
• Project Manager also spends a great deal of time communicating with other professionals via phone, email, and face-to-face meetings to make sure the client/ auditors and other team is consistently aware of any relevant information and issues.
• Build relationships with and serve as a point of contact with external entities.
• He or She must be able to track all parts of the contracted services and update the tools accordingly.

• In conjunction with Advarra Consulting Leadership, provide support to GXP and/or other COEs provided to Clients pertaining to global compliance, quality assurance and clinical trial oversight. This will include, but is not limited to, sending specification notices to consultants, reviewing deliverables, tracking Client and/or project related information, and conducting projects (e.g. audits/assessments, consulting engagements)
• Supervise the resources to Client projects.
• Establishes and ensures commitments are met for the client
• Under the direction of Director/Associate Director, perform consultancy services for Clients, at times serving in a lead role, establishing, cultivating and maintaining relationships with specific Clients as the primary point of contact for service-related Client communication and potentially cross-project issues
• Support the evaluation of processes and ongoing procedural compliance within GXP and/or other COEs and influence process improvement initiatives
• Represent Advarra Consulting on Business Development /Sales calls
• As assigned, advise, or develop departmental Standard Operating Procedures, Guidelines and other tools to support Client consulting services
• Works with Leadership team to resolves staffing issues for complex engagements.
• Produces billable work (target 60-70%)
• Other duties as assigned

Job Requirements
Education

• Bachelor's degree, or equivalent, from an accredited college or university required.
• Preferred: PMP certification, Certifications related to ethics review, research, and/or research compliance (e.g. CIP, RAC, CHRC).

Experience

• Previous experience as a Clinical Trial Manager or Project Management is required
• At least 3-5 years of clinical project management/clinical study management experience at a sponsor or CRO company is required.
• Minimum of three (3) years in the following areas (as appropriate for service line support) Clinical Research, Clinical Trial Manager, Quality Assurance and/or Research & Development experience in pharmaceutical, biopharmaceutical, medical device, Life Science consulting, regulatory, or legal fields.
• Experience with U.S. and international legal and regulatory standards and compliance.
• Experience overseeing CROs/Vendors and investigator sites
• Experience in vendor/site contract review
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook). Preferred Microsoft Project or similar project management software tool.
• Ability to manage a remote team is required.

Knowledge/Skills/Abilities

• GXP, Quality Assurance, and/or Regulatory management experience and knowledge;
• Aptitude and knowledge to provide oversight of, independent Investigator Site Audits, CRO/Vendor Audits, and other assignments
• Strong communication skills, Excellent organization and ability to focus on detail.
• Ability to work independently, while still meeting team deadlines and requirements
• Proficient in Microsoft Office Programs (i.e., Word, Excel, Outlook, Access and PowerPoint)
• Demonstrated working knowledge of regulatory matters related to research development, conduct, oversight, and in human subjects protection.
• Strong Project management and team building skills
• Advanced oral and written communication skills
• Ability to analyze a variety of data points to solve complex problems
• Ability to work independently; planning, organizing, scheduling and completing work within deadlines
• Ability to manage conflicting demands and priorities
• Attention to detail with a high level of accuracy
• Work remotely, within a self-provided, designated work space which includes reliable internet connectivity

Physical and Mental Requirements:

• Sit or stand for extended periods of time at stationary work station
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding and speaking

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EEO Statement

Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)