Medical Writing Manager QC Editing (REMOTE)

inVentiv Health Clinical

  • Basking Ridge, NJ


  • Permanent

  • Full-time

Can be remote – MUST HAVE MEDICAL WRITING QC AND EDITING EXPERIENCE

Job Description:

Provides the operational expertise and leadership to one or more clinical

operations teams to ensure the effective and efficient delivery of all

operational aspects of one or more studies through all phases of Clinical Study

Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate

quality standards including ICH/GCP and applicable regulations.

Qualifications:

  • Life sciences degree or nursing equivalent
  • 5-7 years of experience in a clinical research/a healthcare environment.

Experience

  • Proven clinical development experience of the operational aspects of all

stages of clinical studies preferably working in a Global environment

and/or including monitoring or leading affiliate teams, working with

vendors and/or CROs, drug supply management and planning operational

activities to achieve database lock.

  • Experience of project managing operational aspects of a clinical study

including development of timelines, budgets and resource plans.

  • Good knowledge of ICH GCP.
  • Proven ability to successfully achieve results within a multi-cultural

and geographically diverse team.

  • Experience of working as a part of a large team and leading small study

or functional teams, with a proven ability to be an active member of the

team and motivate and lead a small team to deliver against commitments.

  • Well developed written and verbal communication skills demonstrated by an

ability to present clear instruction/direction to teams at the same level

in the organization and influence at higher levels in the organization.

Main Responsibilities and Accountabilities:

Provides direction and leadership to one or more clinical operations teams

  • Develops operational plans including site monitoring strategies, risk

mitigation strategies, trial budgets, site selection, and clinical

supplies management.

  • Builds effective and efficient high performing operations teams and

ensures team members are aware of their accountabilities,

responsibilities and deliverables.

  • Creates team culture and promotes team spirit.
  • Develops and maintains effective working relationships with SMT members,

with particular focus on affiliate teams, external CRO (for outsourced

teams) and co-development partner study teams.

  • In collaboration with functional management, coaches, mentors, supports

and provides study specific direction to Study Management team members.

  • Oversees the development and maintenance of study specific manuals

created by the GSA.

Contributes to the development and management of the study timelines,

resources, budget, risk and quality plans

  • Ensures operational tracking tools are identified, including systems to

meet the needs of the operations team and ensures reporting to the GSL.

  • Develops and manages clinical study budgets (including HQ budget) and

contributes to the staffing/resourcing plans. Communicates variances in

the budget and action plan for resolution to the GSL.

  • Establishes study milestones and ensures accurate tracking and reporting

of study metrics.

  • Provides operational input into the development of protocol feasibility

questionnaires.

Provides clinical operations expertise to ensure operational feasibility and

delivery

  • Leads the development and finalization of site feasibility

questionnaires.

  • Leads the creation of the study level patient recruitment plan and

retention strategies based on feasibility data and input from the

affiliate teams and consultation with the GSL and OPL.

  • Provides operational input and insight into all study related

documentation (including protocol and informed consent form) and

processes.

  • Analyzes the feasibility data across countries with input from the

affiliates and makes recommendations to the GSL for the strategic country

and site distribution and patient numbers.

Oversees forecasting of clinical/non-clinical supplies

  • Designs drug assumption and supply chain process in partnership with

Pharma Technical Drug Supplies, affiliates and GSL.

  • Oversees the forecasting and management of non-clinical supplies to

ensure sites have supplies to run clinical study.

Delivers the operational elements of the study plan

  • Chairs operations team meeting and organizes the investigator meetings,

monitor training, CRO kick-off meetings.

  • Ensures that reporting of SUSARs is established and maintained for the

duration of the study.

  • Proactively manages actual study level recruitment versus planned patient

recruitment status and communicates variance to the GSL and implements

contingencies in consultation with the GSL.

  • Primary contact with affiliates to maintain oversight of performance,

issues, and their resolution and identify systematic issues and

coordinates any corrective action.

  • Ensures the completion and finalization of any corrective and

preventative action plans resulting from internal site audits.

  • Oversees the maintenance of drugs supplies and resolution of issues with

input from the Pharma Technical Drugs Supplies.

  • Coordinates responses to study questions or issues from Health

Authorities or IRBs/IECs.

  • Provides operational input into the development and tracking of SMT

goals.

Provides the day-to-day operational management of CROs and vendors to ensure

delivery against contracted scope of work

  • Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS,

Reading Centers), including independent negotiation of scope of work,

budgets, performance management, and issue resolution.

  • Develops and executes appropriate site and CRO/vendor audit and quality

plans.

Identifies areas of best practice and process improvements

  • Participates in Pharma Development Operations initiatives and programs as

assigned.

  • Maintains oversight and ensures consistency of the operational aspects

across studies within a project.

Ensures study adherence to ICH/GCP and SOPs

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