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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Exploratory Medicine and Pharmacology Senior Manager


Reference:SCAGOY-275725 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Exploratory Medicine and Pharmacology Senior Manager
Our client, a global pharma organisation based in Cork are currently recruiting for anExploratory Medicine and Pharmacology (EMP) Manager to join their team on a permanent basis. As Exploratory Medicine and Pharmacology Manager you will be responsible forthequalityand delivery of the clinical trial portfolio.You will also provide leadership withrecruiting/onboarding,inspectionreadiness activities, process improvements, and ensure career development plans are in place.

Responsibilities

  • Acts as site leadership for EMP staff
  • Work with EMP leadership to represent consistent messages across all global sites
  • Leverage technicalexpertiseto coachClinical Trial Project Management Associates toensure plansaredelivered ahead of/to plan and onbudget
  • Work with EMP leadershiptoensureplanning databases are accurate andup todate
  • Ensure inspection readiness ofstaff’srespective study teamsand participates as needed in mock/realinspections
  • Oversee andprovidedirection in obtainingappropriate personnel involvementas compliance issues areidentifiedwhich require further action orfollow-up
  • Ensure appropriate escalation of portfolio related issues
  • Manage resource needs and trade-offs acrossareas based on priorityto meet/exceed portfoliomilestones
  • Facilitate discussions within clinical functionsas neededto manage team priorities and address unplanned demands
  • Provide technical coaching andleadership to EMP Operations to enableeffectiveplanning andexecutionof the clinical portfoliotodeliver to meet/exceed milestones
  • Ensure quality in clinical research activities by promoting consistent use of GCPs, global SOPs, and bestpractices
  • Provides timely communication to staff regarding the strategic direction, realignment of new assignments and new processes
  • Facilitates high-level discussions with vendors, as appropriate
  • Leads training in study start up processes for staff
  • Post vacant positions, coordinate interviews, and lead decisions on hiring staff members with a goal of attracting and retaining top talent in theorganization
  • Ensure development plans are in place forstaff
  • Evaluate individual skill level and behaviors, identify &appropriate coachesfor staff toenable them to become proficient in completion of study responsibilities
  • Monitortraining compliance forassistants ensuringtimelycompletion of all required courses
  • Has shared responsibility with training group to ensure that curriculum maps and training programs/courses are maintained appropriately for staffmembersto enable them to perform their job responsibilities. Consult as appropriate on new training programs/courses
  • Provide timely communication to staff regarding the strategic direction, realignment of new assignments and new processes
  • Facilitate high-level discussions with vendors, as appropriate
  • Lead training in study start up processes for staff

Requirements:
  • Bachelors or University degree (scientific or health-related field preferred) and 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred)
  • Demonstrated technical and process expertise in clinical trial development. Must understand the drug development process and interdependencies of various tasks and functional groups
  • Effective communicationskills. Communicates effectively up and down in an organization andmaintainsconfidentiality with respect to strategic and personnel matters.
  • Proven ability to coach others & previous supervisory experience
  • Strong people and leadership skills with demonstrated ability to influence and lead across clinical functions
  • Strong interpersonal, teamwork, and negotiation skills
  • Strong self-management and organizational skills.Must be capable of managing staff virtually, demonstratinginclusivebehaviors
  • Vendor management and contracting experience
  • Demonstrated strong business skills including the ability to understandandsupportplanning processes across clinical functions
  • Travel may be required

For more information please contact Sinéad Cullen on +353879500821 or [email protected]