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Aggregate Reporting Manager

Aggregate Reporting Manager (AdvancedGroup_476049) Princeton, New Jersey

Job Number: 476049

Aggregate Reporting Manager

OVERVIEW
We are currently searching for a skilled professional to join a growing organization committed to clinical excellence as Aggregate Reporting Manager in Princeton, New Jersey. The Aggregate Reporting Manager will support all the roles involved in the creation of Aggregate Safety Reports. Their leadership and production activities will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

  • Support roles involved in creation of Aggregate Safety Reports (ASRs)
  • Facilitate Aggregate Report production activities across organizations
  • Participate in project teams and facilitate coordination of activities required to implement initiatives
  • Ensure synchronization among ASRs as necessary
  • Plan and coordinate time and resources needed for ASR creation
  • Identify all personnel involved in ASR preparation prior to strategy meeting
  • Lead ongoing ASR production meetings
  • Create workflows for each of the ASRs in the document management system
  • Request standard output for ASRs according to project plans timelines
  • Verify contributors are maintaining compliance with project plan time lines
  • Schedule additional meetings as needed to resolve issues
  • Gather ASR approval signatures
  • Provide ASR compliance metrics to management
  • Coordinate and lead 'lessons learned' meeting following ASR submission
  • Contribute to development of new ASR workflow or process
  • Collaborate the drafting of key SOPs and WPs related to ASR processes
  • Draft user guides for document management system
  • Perform other activities as needs arise in the context of ASRs
  • Assist with continuous improvement projects/updates

EXPERIENCE

  • Minimum of 2 years of global aggregate report experience required
  • Detailed knowledge of US, ICH and EU PV and GCP
  • Experience in table generation for aggregate reports
  • Excellent strategic decision making and analytic skills
  • Strong written and verbal communication skills
  • Experience working with Alliance Partners and Managing PV agreements
  • Proficient in the MS-Office/Office 365 suite of software applications (WORD, Excel, PowerPoint)

EDUCATION

  • Minimum of Bachelor’s Degree preferred
  • Pharmacy/Nursing degree preferred

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.