Project Management Associate

Docs International UK Limited
On Application
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
DOCS has partnered with one of the world's leading biopharma companies on a global study management initiative that has created exciting opportunities for professionals with clinical study management experience.

We are looking for talented and motivated candidates to join the team and take part in this long-term, dynamic project.

The ideal candidate will bring experience gained within the clinical research industry on commercial clinical trials. The project will provide exposure across a variety of therapeutic areas with an organization that is at the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development. Experience as a CRA would be beneficial.

The role of the PMA is integral to the project

Key Responsibilities include:

- Supporting the management and oversight of global clinical trials
- Essential document management
- Maintaining study level storyboard for critical timeline oversight
- Compiling IRB/EC submission documentation
- To coordinate, author and manage preparation of clinical trial documentation and training materials (including investigator meetings, site evaluation and initiation training)
- Facilitate development of Investigational Product Information Manual and study specific Important Protocol Deviation list
- Managing processes for planning, procuring and oversight of ancillary clinical supplies
- Creation and management of study specific tools, including: - o Global/country level recruitment and retention materials
- o Authoring and distribution of study newsletters

- Vendor management (including set up, tracking and issue resolution over the life of the study)
- Tracking and collation of study data and metrics utilizing multiple clinical systems
- Preparing clinical study team meeting agendas and minutes, facilitating cross-functional meetings
- Managing global versioning and distribution of documents (e.g. informed consent forms)

Critical Success Factors for the Role include:

- In depth knowledge of drug development processes
- Experience or familiarity with advanced concepts of clinical research
- Demonstrated experience gained within a clinical research environment on clinical studies
- Extensive knowledge of technical, scientific and medical terms
- Advanced Microsoft Office skills. Demonstrable understanding of pivot tables and use of advanced Excel formulae would be a distinct advantage.
- Detailed knowledge of Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to write and present clearly using scientific and clinical terminology
- Experience dealing with time demands, incomplete information or unexpected events
- Excellent communication skills
- Good organizational and planning skills
- Experience working effectively in a team/matrix environment
- Proactivity

What is required

- BA/BS/BSc in life sciences or RN
- At least 2 years' experience gained within a clinical research environment on commercial clinical studies
- Previous biopharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company
- Full-time availability
- Full and valid UK working eligibility
- CRA/clinical trial monitoring experience preferred

Key Competencies:

- Proactivity / Attention to Detail / Teamwork / Strong Written and Oral Communication / Delivery Focus / Flexibility / Initiative / Relationship Building / Policy, Process and Procedural Conformance / Problem Solving / Time Management

What is offered

- Permanent contract of employment
- Full-time
- Office-based in Marlow (Bucks) or near Southampton (Hampshire). Home-based working may be negotiable for the right candidate.
- Salary depending on level of skills and experience plus company benefits (23 days annual leave, pension, healthcare cover, etc.)