QuintilesIMS Nigeria Job Vacancy for a Reg & Start-UP Line Manager for GRSULs
At Quintiles we help healthcare and biopharma companies improve their
probability of success. We do this by connecting our scientific,
therapeutic and analytics expertise with superior delivery. From
advisory through operations, Quintiles and its affiliate companies is
the world’s largest provider of
product development and integrated
healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great
opportunities for a career in world-leading clinical research. Our
global projects, innovative tools and industry leading customers
combined with outstanding support from our leadership team and clear
career mapping allows you to make a difference in patient health.
We are recruiting to fill the position below:
Job Title: Reg & Start-UP Line Manager for GRSULs
Job ID: 1704341
Location: Benin
Purpose
- Direct and manage the delivery of all required start-up,
maintenance and regulatory activities for multi-protocol programs as
determined by either the agreed algorithm or the Sponsor’s requirements,
including pre-award activities, oversight of the scope of work, budget
and resources.
Responsibilities
- The role holder may be required to cover all responsibilities
mentioned below but will be expected to focus on certain
responsibilities for periods of time.
- Accountable for the oversight and execution of Start Up (from
pre-award/bid defense activities up to Maintenance and Investigational
Product (IP) release for all assigned projects in accordance with the
agreed RSU strategy.
- Provide specialist regulatory and technical scientific support
to facilitate efficient initiation and maintenance of clinical trials,
whilst enabling compliance with regulatory requirements.
- Determine regulatory strategy/expectations and parameters for
submissions and all necessary authorizations; identify regulatory
complexity and challenges and offer creative and practical solutions to
support the bid process and subsequent execution of the RSU plan.
- Create, publish and review core scientific, technical and
administrative documentation necessary for enabling study initiation and
maintenance.
- Assess and review regulatory landscape and contribute to
collection, interpretation, analysis and dissemination of accurate
regulatory intelligence. Ensure overall project efficiency and adherence
to project timelines and financial goals; report performance metrics
and out of scope activities as required. Work with Quality Management to
ensure appropriate quality standards for the duration of the start up.
- Mentor and coach colleagues as required and provide technical guidance both within and outside the project.
- Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role.
- May take a proactive role in developing long standing relationships with preferred Quintiles customers.
- Responsible for the development, maintenance and implementation
of the RSU plan according to the Scope of Work and Project Plan within
the agreed strategy, escalating issues where required.
- Ensure cross collaboration across RSU and communication with
regions and countries to successfully implement the agreed RSU plan.
- Provide overall guidance and oversight of multi-site projects
during maintenance phase as an integral member of the study management
team.
- Execute operational strategy/ expectations for maintenance of
clinical study approvals, authorizations and review/ negotiation of
contracts and essential documents.
Qualifications
Required Knowledge, Skills and Abilities:
- Good negotiating and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player; ability
to co-ordinate and collaborate above, across and within complex
projects.
- Good regulatory and/or technical writing skills
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Good presentation skills
- Understanding of study financial management
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Good understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Ability to exercise independent judgment taking calculated risks when making decisions
Minimum Required Education and Experience
- Bachelor's degree in life sciences or related field with 7
years’ relevant experience including demonstrable experience in an
international role; or equivalent combination of education, training and
experience.
Physical Requirements:
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Potential for frequent travel.
How to Apply
Interested and qualified candidates should:
Click here to apply