Clinical Project Associate

WORKING AT MÖLNLYCKE
Are you looking for a great career and want to make your mark?
Please keep on reading but don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for!
Could you help improve healthcare outcomes around the world?
If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below.
We are now looking for a Clinical Project Associate to join our Global Clinical Affairs, Medical and Economic Affairs department. This role is office based at our Headquarters in Gothenburg, Sweden but will operate globally and travel domestic/internationally up to 25 %.
The Clinical Project Associate plays a vital role in the Clinical Operations Team by the successful management of investigator sites and monitoring activities, as well as archiving for assigned clinical studies throughout the entire trial lifecycle. This position is a great opportunity for the motivated and driven person to develop into a Clinical Project Manager role.

PURPOSE OF POSITION
The role is a key contributor to plan, conduct, and report global clinical projects according to applicable guidelines/laws, timelines budget and quality, including the following:
Accountable for study logistics and materials.
Accountable for study documentation and archiving.
Support or lead project management for study delivery.
To support, or lead, compliant execution of clinical studies by being skilled in applicable Standard Operating Procedures (SOP), laws, and regulations.
To improve, and be accountable for, administrative routines and procedures.
As part of the Clinical Operations, the role will operate through internal and external cross functional teams and involved stakeholders, experts, investigators, subcontractors, and authorities. The CPA will have an academic background supporting the key input deliveries.


KEY ACCOUNTABILITIES
Accountable for key documentation processes in clinical projects, i.e.

o Develop and maintain system for investigation files, electronic and/or paper-based as applicable.
o Archiving of databases and Investigation files.
Accountable for management of investigational products and study logistics (eg. ordering, warehousing, shipment, accountability, training, and adaptation of the process).
Lead selected Clinical Investigations and/or selected tasks related to planning, conduct, and closure of clinical projects (e.g. development of Clinical Investigation Plan and Clinical Investigation Reports, site selection and follow-up).
Accountable for study documentation and archive during audits
Project associated budget planning and follow-up.
Review and maintenance of applicable SOP.
Drive operational aspects of assigned clinical investigations (e.g. CRO/site/lab selection, milestones, meetings, resource allocation, enrolment, data consistency, investigation products).
Assist in vendor and site management.


KEY DECISIONS
Study decisions in alignment with manager.
Process decisions for study material and logistics.
Process decisions for study documentation filing and archiving.


CAPABILITIES; QUALIFICATIONS AND EXPERIENCE
Strong feeling of ownership and execution.
Problem solver with a solution oriented mindset and good way in handling challenges and changes.
Accurate, resourceful and creative personality.
Strong communication skills and ability to work with various stakeholders, subcontractors and partners.
Relevant (life science) education on BSc or higher level, e.g. Nursing, Pharmacist etc.
Comfortable working with multiple activities simultaneously and with short deadlines.
Preferably working experience in Clinical Project/Study Management in an international setting.
Proven knowledge of clinical research methodology, GCP, and applicable regulations/laws.
Fluent in English (written and spoken).
Sufficient knowledge of Microsoft Products, with a required drive to learn more complex systems, e.g. JIRA
Please submit your application as soon as possible, we will be reviewing the applications continuously


About Mölnlycke
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialise in:
•Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
•Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
•Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.